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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04040192
Registration number
NCT04040192
Ethics application status
Date submitted
30/07/2019
Date registered
31/07/2019
Date last updated
8/03/2023
Titles & IDs
Public title
A Study to Evaluate Long-Term Maintenance Treatment With Once Daily Crisaborole Ointment 2% in Pediatric and Adult Participants With Mild-to-Moderate Atopic Dermatitis
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Scientific title
A Phase 3, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Maintenance Treatment and Flare Reduction With Crisaborole Ointment, 2%, Once Daily Over 52 Weeks in Pediatric and Adult Participants (Ages 3 Months and Older) With Mild-to-Moderate Atopic Dermatitis, Who Responded to Twice Daily Crisaborole Ointment, 2%, Treatment
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Secondary ID [1]
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2019-000443-28
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Secondary ID [2]
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C3291035
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Crisaborole 2%
Treatment: Drugs - Vehicle
Experimental: Crisaborole 2% - Crisaborole 2% ointment applied once daily (QD)
Placebo Comparator: Vehicle - Vehicle ointment applied once daily (QD)
Treatment: Drugs: Crisaborole 2%
Crisaborole ointment 2%
Treatment: Drugs: Vehicle
Vehicle ointment
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Duration of Flare-Free Maintenance Until Onset of First-Flare During the Double Blind (DB) Period
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Assessment method [1]
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The duration of flare-free maintenance was the time from randomization to the last Investigator's Static Global Assessment (ISGA) and was right censored, if an intercurrent event (eg, death, dropout, loss to follow up, or end of study) occurred before the first flare. When a flare occurred first, the duration of flare free maintenance was the time from randomization to the first flare and was not censored. Duration of flare free maintenance was estimated using the Kaplan-Meier method.
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Timepoint [1]
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From randomization to first flare or last ISGA assessment (up to 52 weeks)
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Primary outcome [2]
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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Assessment method [2]
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An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE was considered a TEAE if the event started on or after the treatment period start date and before end of study (at least 28 days after last dose of study intervention).
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Timepoint [2]
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Crisaborole 2% BID: From start of study intervention in OL period up to 8 weeks ; Vehicle QD and crisaborole 2% QD: From start of study intervention in DB period up to 28 days after last dose of study intervention (maximum of 56 weeks)
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Secondary outcome [1]
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Number of Flare-Free Days During the DB Period
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Assessment method [1]
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Flare - free days was the sum of the duration of flare-free maintenance during the DB maintenance period for each participant.
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Timepoint [1]
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Up to maximum of 52 weeks
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Secondary outcome [2]
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Number of Flares During the DB Period
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Assessment method [2]
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Flare was defined as an ISGA score of >=2. The ISGA is a 5-point scale (range 0 to 4), reflecting a global assessment of AD severity based on erythema, induration/papulation, and oozing/crusting. ISGA score of 2: mild (faint pink erythema with mild induration/papulation and no oozing/crusting) 3: moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting) and 4: severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting).
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Timepoint [2]
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Up to maximum of 52 weeks
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Secondary outcome [3]
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Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged >=12 Years With Baseline Peak Pruritus Numerical Rating Scale (PP NRS) >=3, >=4 and >=3, >=4 Points Reduction in PP NRS
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Assessment method [3]
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Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA>=2) during 52-week DB period evaluated among pruritus responders at randomization. Responders=participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of >=50% improvement in pruritus from baseline obtained at randomization. If event (e.g., death, first flare[ISGA >=2], lost to follow up or end of study) occurred before loss of pruritus response for first flare-free period, duration of pruritus response maintenance was time from randomization to last assessment and was censored. Here,pruritus response maintenance duration was presented for participants aged >=12 years with OL baseline PP NRS >=3, >=4 and >=3, >=4 points reduction from OL baseline to randomization in PP NRS. PP NRS: Participants were asked to rate their itch at worst moment during previous 24 hours on a scale of 0 to 10; 0=no itch and 10=worst itch imaginable".
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Timepoint [3]
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From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
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Secondary outcome [4]
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Secondary: Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Participants Aged 6 to <12 Years With Baseline Patient Reported Itch Severity (PRIS) >=2 and >=2 Points Reduction in PRIS
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Assessment method [4]
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Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset (ISGA>=2) during 52-week DB period. Evaluated among pruritus responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. Pruritus response maintenance=maintenance of >=50% improvement in pruritus from baseline that was obtained at randomization. If an event (e.g., death, first flare [ISGA >=2], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 6 to <12 years with baseline PRIS >=2 and >=2 points reduction from baseline to randomization in PRIS. PRIS: a 5-point scale (range: 0=no itch to 4=worst itch imaginable) and was completed by participants.
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Timepoint [4]
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From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
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Secondary outcome [5]
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Duration of Pruritus Response Maintenance Until Onset of First Flare During the DB Period: Observer Reported Itch Severity Scale (ORIS) in Participants Aged 3 to <6 Months
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Assessment method [5]
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Duration of pruritus response maintenance=time from randomization to loss of pruritus response or first flare onset(ISGA>=2)during52-weekDB period. Evaluated among pruritus responders (success in ISGA, EASI 50) at randomization. Pruritus response maintenance=maintenance of >=50% improvement in pruritus from baseline obtained at randomization. If event(e.g., death, first flare[ISGA >=2], lost to follow up, or end of study) occurred before loss of pruritus response for first flare-free period, duration of maintenance of pruritus response was time from randomization to last assessment and was censored. Here, pruritus response maintenance duration was presented for participants aged 3 to <6 months with OL baseline ORIS>=3 or >=4 and >=3 or >=4 points reduction from OL baseline to randomization in ORIS. Caregivers were asked to rate observation of their child's itch(scratching, rubbing) at worst moment during previous 24 hours on a scale of 0 to 10;0=no itch,10=worst itch imaginable.
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Timepoint [5]
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From randomization up to loss of pruritus response or onset of first flare or the last assessment (maximum of 52 weeks)
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Secondary outcome [6]
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Duration of Maintenance of >=50% Reduction in Eczema Area and Severity Index (EASI) Total Score Until Onset of First Flare During the DB Period
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Assessment method [6]
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EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD. EASI response maintenance = score that does not lose more than 50% of achieved reduction from Day1/Baseline run-in EASI score.
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Timepoint [6]
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From randomization to loss of EASI response or onset of first flare or the last EASI assessment (up to maximum of 52 weeks)
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Secondary outcome [7]
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Duration of Maintenance of Dermatology Life Quality Index (DLQI) Response Until Onset of First Flare During the DB Period
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Assessment method [7]
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Duration of DLQI maintenance=time from randomization to loss of DLQI response during 52-week DB period for responders at randomization. If event(e.g., death, first flare[ISGA >=2], lost to follow up or end of study) occurred before loss of DLQI response, duration of maintenance of DLQI response=time from randomization to last assessment and censored. Responders=participants with success in ISGA,EASI50 criteria. DLQI response maintenance=response that does not lose more than minimal clinical important difference. DLQI =10-item questionnaire, measured impact of skin disease in participants aged >=16 years. Children's DLQI (CDLQI): participants aged 4 to15 years. Each question in DLQI and CDLQI evaluated on 4-point scale (range 0=not at all to 3=very much). Scores from10 items were added for DLQI/CDLQI total score, range:0 (not at all) to 30 (very much). Higher scores=more impact on quality of life of participants/children.
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Timepoint [7]
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From randomization to loss of DLQI response or onset of first flare or the last assessment up to first flare (up to maximum of 52 weeks)
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Secondary outcome [8]
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Duration of Maintenance of Patient Oriented Eczema Measure (POEM) Response Until Onset of First Flare During the DB Period
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Assessment method [8]
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POEM was a 7-item participant reported outcome measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item was scored as: no days=0, 1-2 days=1, 3-4 days=2, 5-6 days=3 and every day=4. The total score ranged from 0 to 28, where higher score indicated greater severity. POEM response maintenance was defined as the response that does not lose more than minimal clinical important difference. Duration of POEM maintenance was time from randomization to loss of POEM response during 52-week DB period for responders at randomization. Responders were defined as participants with success in ISGA and EASI50 criteria. If an event (e.g., death, first flare [ISGA >=2], lost to follow up, or end of study) occurred before loss of POEM response, duration of maintenance of POEM response was time from randomization to last assessment and was censored. Proxy POEM was used for participants aged 3 months to <12 years.
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Timepoint [8]
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From randomization to loss POEM response or onset of first flare or the last assessment up to the first flare (up to maximum of 52 weeks)
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Secondary outcome [9]
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Investigator's Static Global Assessment (ISGA) Score for the First Flare Period
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Assessment method [9]
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ISGA:5- point global assessment scale of AD severity, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. First flare period was the time from the onset of flare (ISGA>=2) during DB maintenance period where the participant was switched to receive open-label crisaborole ointment 2%, BID for up to 12 weeks until resolution of flares.
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Timepoint [9]
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Week 0 (Day 1), Week 4, Week 8 and Week 12
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Secondary outcome [10]
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EASI Score for the First Flare Period
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Assessment method [10]
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EASI assessed severity of AD, based on severity of lesion clinical signs (erythema[E], induration/papulation[I], excoriation[Ex], lichenification[L]) and % body surface area(BSA) affected.Each of clinical signs scored separately for each of 4 body regions (head and neck[h], upper limbs[u], trunk[t] [including axillae and groin], lower limbs[l] [including buttocks]) on 4-point scale: 0= absent; 1=mild; 2= moderate; 3= severe.EASI area score(A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.First flare period=time from onset of flare(ISGA>=2) during DB maintenance period where participant was switched to receive open-label crisaborole ointment 2%,BID for up to 12 weeks until resolution of flares.
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Timepoint [10]
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Week 0 (Day 1), Week 4, Week 8 and Week 12
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Secondary outcome [11]
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Duration (Days) of Flare Period
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Assessment method [11]
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Duration of flare period was average duration calculated from sum of durations divided by number of flares for each participant.
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Timepoint [11]
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Up to 52 weeks
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Secondary outcome [12]
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Percent Change From Baseline in EASI Scores at Weeks 2, 4, 6 and 8: OL Run-in Period
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Assessment method [12]
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EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
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Timepoint [12]
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Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
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Secondary outcome [13]
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Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: DB Period
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Assessment method [13]
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EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
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Timepoint [13]
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Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [14]
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Percent Change From Baseline in EASI Scores at Weeks 0, 4, 8 and 12: First Flare Treatment Period
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Assessment method [14]
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EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to % BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
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Timepoint [14]
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Baseline (last observation up to and including the randomization day of DB period),Weeks 0, 4, 8 and 12
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Secondary outcome [15]
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Percent Change From Baseline in EASI Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52: First Flare Free Period
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Assessment method [15]
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EASI assessed severity of AD, based on severity of lesion clinical signs (erythema [E], induration/papulation [I], excoriation [Ex], lichenification [L]) and % body surface area (BSA) affected. Each of clinical signs scored separately for each of 4 body regions (head and neck [h], upper limbs [u], trunk [t] [including axillae and groin], lower limbs [l] [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score (A) according to %BSA with AD: 0 (0%), 1(>0 to <10%), 2(10 to <30%), 3(30 to <50%), 4(50 to <70%), 5(70 to <90%), 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh + Ih + Exh + Lh) + 0.2*Au*(Eu + Iu + ExU + Lu) + 0.3*At*(Et +It + Ext + Lt) + 0.4*Al*(El + Il + Exl + Ll). Total EASI score ranged from 0.0 to 72.0, higher score = greater severity of AD.
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Timepoint [15]
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Baseline (last observation up to and including the randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [16]
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Change From Baseline in ISGA Scores at Weeks 2, 4, 6 and 8 for OL run-in Period
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Assessment method [16]
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ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
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Timepoint [16]
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Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
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Secondary outcome [17]
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Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for DB Period
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Assessment method [17]
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ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
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Timepoint [17]
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Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [18]
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Change From Baseline in ISGA Scores at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for First Flare Free Period
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Assessment method [18]
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ISGA is a 5- point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding the scalp). Score ranged from 0 to 4: where 0= clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD.
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Timepoint [18]
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Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [19]
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Change From Baseline in ISGA Scores at Weeks 0, 4, 8 and 12 for First Flare Treatment Period
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Assessment method [19]
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ISGA:5-point global assessment scale, used to characterize overall disease severity across all treatable AD lesions (excluding scalp). Score ranged:0 to 4,where 0=clear(minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1=almost clear(trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2=mild(faint pink erythema with mild induration/papulation and no oozing/crusting), 3=moderate(pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4=severe(deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicate greater severity of AD. The period for which OL crisaborole 2% ointment BID was initiated for treatment of flare developed during DB maintenance until resumption of DB treatment was defined as flare treatment period.
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Timepoint [19]
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Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12
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Secondary outcome [20]
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Change From Baseline in Treatable Percent Body Surface Area (% BSA): OL Run-in Period
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Assessment method [20]
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The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
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Timepoint [20]
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Baseline (last observation up to and including the randomization day) Weeks 2, 4, 6 and 8
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Secondary outcome [21]
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Change From Baseline in Treatable %BSA: DB Period
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Assessment method [21]
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The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
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Timepoint [21]
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Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
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Secondary outcome [22]
0
0
Change From Baseline in Treatable %BSA: First Flare Free Period
Query!
Assessment method [22]
0
0
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Query!
Timepoint [22]
0
0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [23]
0
0
Change From Baseline in Treatable %BSA: First Flare Period
Query!
Assessment method [23]
0
0
The extent (%) to which a body region was involved with AD was determined using handprint method. Four body regions evaluated: head and neck (hn), upper limbs (ul), trunk (tr) (including axillae) and lower limbs (ll) (including buttocks). Total number of handprints=10 for hn, 20 for ul, 30 for tr, 40 for ll in participants aged >=8 years; 20 for hn, 20 for ul, 30 for tr, 30 for ll in participants aged 3 months to 7 years. Surface area of body region equivalent to 1 handprint: 10% for hn, 5% for ul, 3.33% for tr, 2.5% for ll in participants aged >=8 years; 5% for hn, 5% for ul, 3.33% for tr, 3.33% for ll in participants aged 3 months to 7 years. % BSA for a body region= total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual=sum of % BSA across all 4 body regions and ranged from 0 to 100%, with higher values representing greater extent of BSA involvement with AD.
Query!
Timepoint [23]
0
0
Baseline (last observation up to and including the randomization day), Weeks 0, 4, 8 and 12
Query!
Secondary outcome [24]
0
0
Change From Baseline in Most Commonly Affected Atopic Dermatitis (AD) % BSA: DB Period
Query!
Assessment method [24]
0
0
The investigators were required to draw the skin areas affected by AD for each participant in a body map and the most commonly affected BSA was documented.
Query!
Timepoint [24]
0
0
Baseline (last observation up to and including the randomization day), Weeks 24 and 52
Query!
Secondary outcome [25]
0
0
Night Time Itch Score for Participants >=12 Years of Age: OL Run-in Period
Query!
Assessment method [25]
0
0
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Query!
Timepoint [25]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [26]
0
0
Night Time Itch Score for Participants >=12 Years of Age: DB Period
Query!
Assessment method [26]
0
0
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Query!
Timepoint [26]
0
0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [27]
0
0
Night Time Itch Score for Participants >=12 Years of Age: First Flare Period
Query!
Assessment method [27]
0
0
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Query!
Timepoint [27]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [28]
0
0
Night Time Itch Score for Participants >=12 Years of Age: First Flare Free Period
Query!
Assessment method [28]
0
0
The severity and frequency of itch (pruritus) during the night due to AD was assessed using a horizontal scale. Participants 12 years of age or older were asked to assess their worst itching and frequency of itching due to AD during their most recent night's sleep on a scale of 0 to 10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch. Scale range of Frequency of night time itch was 0 to 10, where 0=no and 10=the most frequency imaginable. Higher score indicated higher frequency.
Query!
Timepoint [28]
0
0
Baseline (last observation up to and including the randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [29]
0
0
AD Skin Pain Scores for Participants >=12 Years of Age: OL Run-in Period
Query!
Assessment method [29]
0
0
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Query!
Timepoint [29]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [30]
0
0
AD Skin Pain Scores for Participants >=12 Years of Age: DB Period
Query!
Assessment method [30]
0
0
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Query!
Timepoint [30]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [31]
0
0
AD Skin Pain Scores for Participants >=12 Years of Age: First Flare Period
Query!
Assessment method [31]
0
0
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain numerical rating scale (NRS). Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Query!
Timepoint [31]
0
0
Weeks 0, 4, 8, 12
Query!
Secondary outcome [32]
0
0
AD Skin Pain Scores: for Participants >=12 Years of Age First Flare Free Period
Query!
Assessment method [32]
0
0
Participants 12 years of age or older were asked to assess their worst skin pain due to AD at the analysis time, with the question: 'AD skin pain right now' using the skin pain NRS. Skin pain NRS was a 11-point horizontal scale anchored at 0 and 10, with 0 representing "no pain" and 10 representing "worst pain imaginable." Higher scores indicated worse pain.
Query!
Timepoint [32]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [33]
0
0
Patient/Observer Global Impression of Severity Score: OL Run-in Period
Query!
Assessment method [33]
0
0
Patient/Observer Global Impression of Severity (PGIS/OGIS) is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [33]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [34]
0
0
Patient/Observer Global Impression of Severity Score: DB Period
Query!
Assessment method [34]
0
0
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [34]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [35]
0
0
Patient/Observer Global Impression of Severity Score: First Flare Period
Query!
Assessment method [35]
0
0
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [35]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [36]
0
0
Patient/Observer Global Impression of Severity Score: First Flare Free Period
Query!
Assessment method [36]
0
0
PGIS/OGIS is a single item participant or observer rated measure of the participant's AD condition severity at a given point in time using a 7-point rating scale, which ranges from 1 to 7, where 1=not present to 7=extremely severe. The PGIS was completed by all participants >=12 years of age and OGIS was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [36]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [37]
0
0
Patient/Observer Global Impression of Change Score: OL Run-in Period
Query!
Assessment method [37]
0
0
Patient/Observer Global Impression of Change (PGIC/OGIC) is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [37]
0
0
Weeks 2, 4, 6 and 8
Query!
Secondary outcome [38]
0
0
Patient/Observer Global Impression of Change Score: DB Period
Query!
Assessment method [38]
0
0
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [38]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [39]
0
0
Patient/Observer Global Impression of Change Score: First Flare Period
Query!
Assessment method [39]
0
0
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [39]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [40]
0
0
Patient/Observer Global Impression of Change Score: First Flare Free Period
Query!
Assessment method [40]
0
0
PGIC/OGIC is a single item instrument using 7-point rating scale and was used to determine global improvement at a given point in time since the start of study drug. The scores ranged from 1=very much improved to 7=very much worse. The PGIC was completed by all participants >=12 years of age and OGIC was completed by the observer for participants 3 months-<12 years of age.
Query!
Timepoint [40]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [41]
0
0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: OL Run-in Period
Query!
Assessment method [41]
0
0
The Medical Outcomes Study (MOS) Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Query!
Timepoint [41]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [42]
0
0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: DB Period
Query!
Assessment method [42]
0
0
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Query!
Timepoint [42]
0
0
Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [43]
0
0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Period
Query!
Assessment method [43]
0
0
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Query!
Timepoint [43]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [44]
0
0
Medical Outcome Study Sleep Scale Score in Participants >=12 Years of Age: First Flare Free Period
Query!
Assessment method [44]
0
0
MOS Sleep Scale is a 12-item measure that is segregated into subscales addressing seven sleep domains (i.e. sleep disturbance, snoring, short of breath or headache, adequacy of sleep, somnolence, sleep problems index I and sleep problems index II) and a single item assessing quantity of sleep. Quantity of sleep scores ranged from 0 to 24 (number of hours slept) and Optimal Sleep score ranged from 0 (no) to 1(yes) based on whether the participant slept for 7-8 hours per night, All other subscales including sleep problems index 1 and 2:were scored on a range of 0 to 100 where, higher scores=greater impairment. Observed scores for each individual sleep domain and quantity of sleep are reported in this outcome measure.
Query!
Timepoint [44]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [45]
0
0
European Quality of Life-5 Dimension 5-Level (EQ-5D-5L) Index Score in Participants Greater Than or Equal to (>=) 18 Years of Age: OL Run-in Period
Query!
Assessment method [45]
0
0
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
Query!
Timepoint [45]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [46]
0
0
European Quality of Life-5 Dimension Youth (EuroQoL EQ-5D Y) Index Score in Participants Between 8-17 Years of Age: OL Run-in Period
Query!
Assessment method [46]
0
0
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Query!
Timepoint [46]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [47]
0
0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Query!
Assessment method [47]
0
0
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant
Query!
Timepoint [47]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [48]
0
0
EuroQoL EQ-5D-5L Visual Analog Scale (VAS) Score in Participants >= 18 Years of Age: OL Run-in Period
Query!
Assessment method [48]
0
0
EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
Query!
Timepoint [48]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [49]
0
0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age : OL-Run-in Period
Query!
Assessment method [49]
0
0
EQ-5D Y VAS was used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Query!
Timepoint [49]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [50]
0
0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: OL Run-in Period
Query!
Assessment method [50]
0
0
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Query!
Timepoint [50]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [51]
0
0
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: DB Period
Query!
Assessment method [51]
0
0
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQoL. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
Query!
Timepoint [51]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [52]
0
0
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: DB Period
Query!
Assessment method [52]
0
0
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Query!
Timepoint [52]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [53]
0
0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: DB Period
Query!
Assessment method [53]
0
0
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
Query!
Timepoint [53]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [54]
0
0
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: DB Period
Query!
Assessment method [54]
0
0
EQ-5D-5L VAS to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
Query!
Timepoint [54]
0
0
Baseline (the last observation up to and including Day 1 of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [55]
0
0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: DB Period
Query!
Assessment method [55]
0
0
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Query!
Timepoint [55]
0
0
Baseline (the last observation up to and including Day 1 of OL period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [56]
0
0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: DB Period
Query!
Assessment method [56]
0
0
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Query!
Timepoint [56]
0
0
Baseline (the last observation up to and including Day 1 of DB period),Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [57]
0
0
EuroQoL EQ-5D-5L Index Scores in Participants >= 18 Years of Age: First Flare Period
Query!
Assessment method [57]
0
0
EQ-5D-5L: standardized participant completed questionnaire consisted of 2 components: a health state profile/a single utility index value and an optional VAS. EQ-5D health state profile/a single utility index value had 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems. Responses to 5 dimensions comprised a health state/a single utility index value. E.g. if a participant responded "no problems" for each 5 dimensions, then health state was coded as "11111" with a predefined index value to it. Every health state (coded as combination of responses on each of 5 dimensions) had a unique predefined utility index value assigned to it, by EuroQol. US value sets (with all possible health states) was used for adults in the study and total scores ranged from 1 to -0.109. Higher (positive) scores = better health state.
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Timepoint [57]
0
0
Weeks 0, 4, 8 and 12
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Secondary outcome [58]
0
0
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Period
Query!
Assessment method [58]
0
0
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Query!
Timepoint [58]
0
0
Weeks 0, 4, 8 and 12
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Secondary outcome [59]
0
0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Period
Query!
Assessment method [59]
0
0
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
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Timepoint [59]
0
0
Weeks 0, 4, 8 and 12
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Secondary outcome [60]
0
0
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Period
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Assessment method [60]
0
0
EQ-5D-5L VAS was used to record participant's rating for his/her current health-related quality of life state on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state.
Query!
Timepoint [60]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [61]
0
0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Period
Query!
Assessment method [61]
0
0
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Query!
Timepoint [61]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [62]
0
0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Period
Query!
Assessment method [62]
0
0
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Query!
Timepoint [62]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [63]
0
0
EuroQoL EQ-5D Y Index Scores in Participants >= 18 Years of Age: First Flare Free Period
Query!
Assessment method [63]
0
0
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Query!
Timepoint [63]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [64]
0
0
EuroQoL EQ-5D Y Index Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Query!
Assessment method [64]
0
0
EQ-5D-Y: child-friendly version of EQ-5D questionnaire related to health status. Health state profile assessed health in 5 dimensions (mobility; looking after myself; doing usual activities; having pain or discomfort; feeling worried, sad or unhappy) used to obtain an index score, each of which had three levels of response (no problems/no pain/not worried, some problems/some pain/a bit worried, a lot of problems/a lot of pain/very worried). Participants indicated their health state by choosing the appropriate level from each dimension. The 5 digit health states thus obtained for each dimension were then converted into a single median index value. A health state index score was calculated from individual health profiles using a USA scoring algorithm. Health state index scores generally ranged from -0.109 to 1, where,-0.109= the worst health status, 1= full health. Higher the score the better the health status. A positive change from baseline indicated improvement in health status.
Query!
Timepoint [64]
0
0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [65]
0
0
EuroQoL EQ-5D Y Proxy Index Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Query!
Assessment method [65]
0
0
EQ-5D-Y:child-friendly version of EQ-5D questionnaire related to health status.Health state profile assessed health in 5 dimensions(Mobility;Looking After Myself;Doing Usual Activities;Having Pain or Discomfort;Feeling Worried,Sad or Unhappy)used to obtain index score,each of which had three levels of response(no problems/no pain/not worried,some problems/some pain/a bit worried,a lot of problems/a lot of pain/very worried).Participants indicated health state by choosing appropriate level from each dimension.5-digit health states obtained for each dimension were converted into single median index value using index value calculator,recommended by EuroQoL group.Health state index score calculated from individual health profiles using USA scoring algorithm. Scores ranged from -0.109 to 1,where, -0.109=worst health status, 1=full health. Higher score=better health status.Positive change from baseline indicated improvement in health status.Proxy version filled by care-giver of participant.
Query!
Timepoint [65]
0
0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [66]
0
0
EuroQoL EQ-5D-5L VAS Scores in Participants >= 18 Years of Age: First Flare Free Period
Query!
Assessment method [66]
0
0
EQ-5D-5L VAS was used to record participant's rating for current health-related quality of life state on vertical VAS (0-100);0=worst imaginable health state;100=best imaginable health state.
Query!
Timepoint [66]
0
0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [67]
0
0
EuroQoL EQ-5D Y VAS Scores in Participants Between 8-17 Years of Age: First Flare Free Period
Query!
Assessment method [67]
0
0
EQ-5D Y VAS was a child-friendly version of EQ-5D questionnaire related to health status used to record participant's rating for his/her current health-related quality of life state on vertical VAS (0-100);0 = worst imaginable health state and 100 = best imaginable health state.
Query!
Timepoint [67]
0
0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [68]
0
0
EuroQoL EQ-5D Y Proxy VAS Scores in Participants Between 2-7 Years of Age: First Flare Free Period
Query!
Assessment method [68]
0
0
EQ-5D Y proxy VAS assessed the caregiver's impression of participants health state on a vertical VAS (range: 0 to 100), where, 0 (the worst imaginable health) to 100 (the best imaginable health).
Query!
Timepoint [68]
0
0
Baseline (the last observation up to and including randomization day of DB period), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [69]
0
0
Percent Work Time Missed Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Query!
Assessment method [69]
0
0
WPAI plus CIQ was a 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1= currently employed; Q2= work hours missed due to health problems; Q3= work hours missed due to other reasons; Q4= hours actually worked; Q5= degree health affected productivity while working (0-10 scale, higher scores = less productivity); Q6= classes attended in academic setting or not; Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, higher scores = less productivity). Percent work time missed was calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%, higher scores = greater impairment and less productivity.
Query!
Timepoint [69]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [70]
0
0
Percent Impairment While Working Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Query!
Assessment method [70]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were:Q1= currently employed;Q2= work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4= hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7= class hours missed due to health problems; Q8= class hours actually attended; Q9= degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10= degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent impairment while working due to health problem was calculated as: 100*Q5/10 and score ranged from 0-100%,higher scores =greater impairment and less productivity.
Query!
Timepoint [70]
0
0
Weeks 0, 2, 4, 6 and 8
Query!
Secondary outcome [71]
0
0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment (WPAI) Questionnaire Plus Classroom Impairment Questions (CIQ): OL Run-in Period
Query!
Assessment method [71]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities (0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]},score ranged:0-100%,high numbers=greater impairment and less productivity.
Query!
Timepoint [71]
0
0
Weeks 0, 2, 4, 6 and 8
Query!
Secondary outcome [72]
0
0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Query!
Assessment method [72]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Query!
Timepoint [72]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [73]
0
0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Query!
Assessment method [73]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [73]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [74]
0
0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Query!
Assessment method [74]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past7days.Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity).Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]},score range:0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [74]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [75]
0
0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: OL Run-in Period
Query!
Assessment method [75]
0
0
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [75]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [76]
0
0
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [76]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [76]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [77]
0
0
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [77]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [77]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [78]
0
0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [78]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked;Q5=degree health affected productivity while working(0-10 scale, high scores=less productivity);Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity);Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]}, score ranged: 0-100%, high numbers=greater impairment and less productivity.
Query!
Timepoint [78]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [79]
0
0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [79]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Query!
Timepoint [79]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [80]
0
0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [80]
0
0
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [80]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [81]
0
0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [81]
0
0
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]}, score range:0-100%, higher numbers=greater impairment and less productivity.
Query!
Timepoint [81]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [82]
0
0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: DB Period
Query!
Assessment method [82]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores=less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores= less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [82]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [83]
0
0
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [83]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5= degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Query!
Timepoint [83]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [84]
0
0
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [84]
0
0
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Query!
Timepoint [84]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [85]
0
0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [85]
0
0
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity: regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]}, score ranged:0-100%, high numbers=greater impairment and less productivity.
Query!
Timepoint [85]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [86]
0
0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [86]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Query!
Timepoint [86]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [87]
0
0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [87]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [87]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [88]
0
0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [88]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]}, score range:0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [88]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [89]
0
0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Free Period
Query!
Assessment method [89]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, score ranged from 0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [89]
0
0
Baseline (the last observation up to and including randomization day), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Query!
Secondary outcome [90]
0
0
Percent Work Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [90]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores=less productivity). Percent work time missed due to health problem calculated as: Q2*100/(Q2+Q4) and score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Query!
Timepoint [90]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [91]
0
0
Percent Impairment While Working Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [91]
0
0
WPAI+CIQ: 10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=hours missed due to health problems; Q3=hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=hours missed due to health problems; Q8=hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities (0-10 scale, high scores =less productivity). Percent impairment while working due to health problem calculated as: 100*Q5/10 score ranged from 0-100%, higher numbers=greater impairment and less productivity.
Query!
Timepoint [91]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [92]
0
0
Percent Overall Work Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [92]
0
0
WPAI+CIQ: 10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working(0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall impairment while working due to health problem calculated as:100*{Q2/(Q2+Q4)+[(1- Q2/(Q2+Q4))×(Q5/10)]}, score ranged:0-100%, high numbers=greater impairment and less productivity.
Query!
Timepoint [92]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [93]
0
0
Percent Class Time Missed Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [93]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent class time missed due to health problem calculated as: Q7*100/(Q7+Q8) and score ranged from 0-100% where higher numbers=greater impairment and less productivity.
Query!
Timepoint [93]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [94]
0
0
Percent Impairment While in Class Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [94]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions:Q1=currently employed;Q2=work hours missed due to health problems;Q3=work hours missed due to other reasons;Q4=hours actually worked; Q5 = degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not;Q7=class hours missed due to health problems;Q8=class hours actually attended;Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent impairment while in class was calculated as: 100*Q9/10 and score ranged from 0-100% where higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [94]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [95]
0
0
Percent Overall Class Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [95]
0
0
WPAI+CIQ:10-item questionnaire to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions were: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending (0-10 scale, high scores = less productivity); Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent overall class impairment due to health problem calculated as: 100*{Q7/(Q7+Q8)+[(1- Q7/(Q7+Q8))×(Q9/10)]}, score range:0-100%, higher numbers=greater impairment and less productivity.
Query!
Timepoint [95]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [96]
0
0
Percent Activity Impairment Using Work Productivity and Activity Impairment Questionnaire Plus Classroom Impairment Questions: First Flare Period
Query!
Assessment method [96]
0
0
WPAI+CIQ:10-item questionnaire used to assess degree to which AD affected work productivity and regular activities over past 7 days. Questions: Q1=currently employed; Q2=work hours missed due to health problems; Q3=work hours missed due to other reasons; Q4=hours actually worked; Q5=degree health affected productivity while working (0-10 scale, high scores =less productivity); Q6=classes attended in academic setting or not; Q7=class hours missed due to health problems; Q8=class hours actually attended; Q9=degree health affected productivity while attending(0-10 scale, high scores = less productivity);Q10=degree health affected productivity in regular daily activities(0-10 scale, high scores =less productivity). Percent activity impairment due to health problem calculated as: 100*Q10/10, scores ranged from 0-100%,higher numbers=greater impairment and less productivity.
Query!
Timepoint [96]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [97]
0
0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale (HADS): OL Run-in Period
Query!
Assessment method [97]
0
0
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-anxiety (HADS-A) and HADS-depression (HADS-D), each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Query!
Timepoint [97]
0
0
Baseline (last observation up to and including Day 1 of OL period), Weeks 2, 4, 6 and 8
Query!
Secondary outcome [98]
0
0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: DB Period
Query!
Assessment method [98]
0
0
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Query!
Timepoint [98]
0
0
Baseline (last observation up to and including randomization day), Week 8, 16, 32 and end of treatment [Week 52]
Query!
Secondary outcome [99]
0
0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Period
Query!
Assessment method [99]
0
0
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Query!
Timepoint [99]
0
0
Weeks 0, 4, 8 and 12
Query!
Secondary outcome [100]
0
0
Total Anxiety and Depression Scores Measured Using Hospital Anxiety and Depression Scale: First Flare Free Period
Query!
Assessment method [100]
0
0
HADS was a validated 14-item questionnaire to assess states of anxiety and depression over the past week. HADS consisted of 2 subscales: HADS-A and HADS-D, each of which comprised of 7 items. Each item was rated on a 4-point scale, with scores ranging from 0 to 3, where higher scores indicated more anxiety/depression symptoms. HADS-A assessed state of generalized anxiety. HADS-A total score = sum of all 7 items with score ranging from 0 (no presence of anxiety) to 21 (severe feeling of anxiety); higher score indicated greater severity of anxiety. HADS-D assessed the state of lost interest and diminished pleasure response. HADS-D total score = sum of all 7 items with score ranging from 0 (no presence of depression) to 21 (severe feeling of depression); higher score indicated greater severity of depression symptoms.
Query!
Timepoint [100]
0
0
Baseline (last observation up to and including the randomization day of DB period), Weeks 8, 16 and 32
Query!
Eligibility
Key inclusion criteria
- Male or female
- 3 months of age and older
- Confirmed diagnosis of atopic dermatitis according to Hanifin and Rajka criteria
- Minimum of 5% BSA affected by atopic dermatitis
- ISGA score of Mild (2) or Moderate (3)
Query!
Minimum age
3
Months
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Has any clinically significant medical disorder, condition, or disease (including active
or potentially recurrent non AD dermatological conditions and known genetic dermatological
conditions that overlap with AD, such as Netherton syndrome).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
12/09/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/01/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
620
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
0
0
Australian Clinical Research Network - Maroubra
Query!
Recruitment postcode(s) [1]
0
0
2035 - Maroubra
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Nebraska
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Ohio
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Oklahoma
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Tennessee
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Texas
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Utah
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Virginia
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
Ontario
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Saskatchewan
Query!
Country [17]
0
0
China
Query!
State/province [17]
0
0
Beijing
Query!
Country [18]
0
0
China
Query!
State/province [18]
0
0
Fujian
Query!
Country [19]
0
0
China
Query!
State/province [19]
0
0
Guangdong
Query!
Country [20]
0
0
China
Query!
State/province [20]
0
0
Hubei
Query!
Country [21]
0
0
China
Query!
State/province [21]
0
0
Jiangxi
Query!
Country [22]
0
0
China
Query!
State/province [22]
0
0
Shanghai
Query!
Country [23]
0
0
China
Query!
State/province [23]
0
0
Tianjin
Query!
Country [24]
0
0
China
Query!
State/province [24]
0
0
Yunnan
Query!
Country [25]
0
0
China
Query!
State/province [25]
0
0
Zhejiang
Query!
Country [26]
0
0
Israel
Query!
State/province [26]
0
0
Ramat - Gan
Query!
Country [27]
0
0
Turkey
Query!
State/province [27]
0
0
Istanbul
Query!
Country [28]
0
0
Turkey
Query!
State/province [28]
0
0
Kayseri
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Pfizer
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will evaluate crisaborole therapy once daily (QD) as a long-term topical
maintenance therapy for the reduction of flare in responders to crisaborole twice daily (BID)
treatment.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04040192
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
Query!
Address
0
0
Pfizer
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04040192
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