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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/NCT04664153
Registration number
NCT04664153
Ethics application status
Date submitted
6/12/2020
Date registered
11/12/2020
Date last updated
26/08/2022
Titles & IDs
Public title
Study To Assess Efficacy, Safety, Tolerability And Pharmacokinetics Of PF-07038124 Ointment In Participants With Atopic Dermatitis Or Plaque Psoriasis
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Scientific title
A PHASE 2A, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-07038124 OINTMENT FOR 6 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE ATOPIC DERMATITIS OR PLAQUE PSORIASIS
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Secondary ID [1]
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2020-003977-23
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Secondary ID [2]
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C3941002
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Universal Trial Number (UTN)
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Trial acronym
EMPORIA
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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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Plaque Psoriasis
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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 - PF-07038124 ointment
Treatment: Drugs - Vehicle ointment
Experimental: atopic dermatitis - PF-07038124 ointment -
Placebo Comparator: atopic dermatitis - vehicle ointment -
Experimental: plaque psoriasis - PF-07038124 ointment -
Experimental: plaque psoriasis - vehicle ointment -
Treatment: Drugs: PF-07038124 ointment
PF-07038124 ointment at 0.01% with QD dosing for 6 weeks
Treatment: Drugs: Vehicle ointment
Vehicle ointment with QD dosing for 6 weeks
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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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Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6 for AD Participants
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Assessment method [1]
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EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
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Timepoint [1]
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Baseline, Week 6
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Primary outcome [2]
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Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 6 for Plaque Psoriasis Participants
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Assessment method [2]
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Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.
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Timepoint [2]
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Baseline, Week 6
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Secondary outcome [1]
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Percentage of AD Participants Achieving Investigator's Global Assessment (IGA) Score of Clear (0) or Almost Clear (1) (on a 5-Point Scale) and a Reduction From Baseline of >=2 Points at Week 6
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Assessment method [1]
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IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared-light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. In this OM, percentages of participants with an IGA score of 0 or 1 and a reduction of >=2 from Baseline in IGA score are reported.
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Timepoint [1]
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Baseline, Week 6
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Secondary outcome [2]
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Percentage of AD Participants Achieving EASI 75 (75% Improvement From Baseline) at Weeks 1, 2, 4, 6 and Follow-up (FUP)/End of Study (EOS)
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Assessment method [2]
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EASI evaluated severity of participants' AD based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk and lower limbs) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD. EASI 75 response was defined as at least a 75 percent (%) reduction in EASI relative to Baseline.
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Timepoint [2]
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Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [3]
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Percentage of AD Participants Having >=4 Points of Reduction in Weekly Averages of Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 4 and 6
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Assessment method [3]
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The PP-NRS was a daily patient-reported assessment of intensity of pruritus on an 11-point numerical rating scale, ranging from 0 ('No Itch) to 10 ('Worst Itch Imaginable') with a 24 hour recall period. For the PP-NRS score, baseline was defined as the average of all values recorded between Day -7 and Day -1. In this OM, percentages of AD participants with >=4 points of reduction in weekly averages of PP-NRS from baseline are reported (percentage based on number of participants with baseline >=4).
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Timepoint [3]
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Baseline, Weeks 1, 2, 4 and 6
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Secondary outcome [4]
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Change From Baseline in EASI Total Score at Weeks 1, 2, 4, 6 and FUP/EOS for AD Participants
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Assessment method [4]
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EASI evaluated severity of participants' AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of BSA affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 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); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
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Timepoint [4]
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Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [5]
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Percentage of AD Participants Achieving IGA Score of Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
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Assessment method [5]
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IGA assessed severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. In this OM, percentages of participants with an IGA score of 0 or 1 are reported.
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Timepoint [5]
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Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [6]
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Percentage of Psoriasis Participants With Physician Global Assessment (PGA) Score Clear (0) or Almost Clear (1) (on a 5-Point Scale) and >=2 Points Improvement From Baseline at Week 6
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Assessment method [6]
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The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 and an improvement of >=2 from Baseline in PGA score are reported.
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Timepoint [6]
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Baseline, Week 6
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Secondary outcome [7]
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Percentage of Psoriasis Participants Achieving PASI 75 (75% or Greater Improvement From Baseline) at Weeks 1, 2, 4, 6 and FUP/EOS
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Assessment method [7]
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The PASI quantified the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI was a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score could vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
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Timepoint [7]
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Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [8]
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Percentage of Psoriasis Participants Who Achieved a Psoriasis Symptoms Inventory (PSI) Score of 0 (Not at All) or 1 (Mild) on Every Item at Weeks 1, 2, 4, 6 and FUP/EOS
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Assessment method [8]
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PSI was a self-administered 8 item questionnaire that measured the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure included concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5 point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. In this OM, percentages of participants with a PSI score of 0 or 1 on every item at weeks 1, 2, 4, 6 and FUP/EOS are reported.
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Timepoint [8]
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Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [9]
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Change From Baseline in PASI Scores at Weeks 1, 2, 4 and FUP/EOS
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Assessment method [9]
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Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.
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Timepoint [9]
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Baseline, Weeks 1, 2, 4 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [10]
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Percent Change From Baseline in PASI Scores at Weeks 1, 2, 4, 6 and FUP/EOS
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Assessment method [10]
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Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease, where higher scores = greater severity of psoriasis.
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Timepoint [10]
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Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [11]
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Percentage of Psoriasis Participants With PGA Score Clear (0) or Almost Clear (1) at Weeks 1, 2, 4, 6 and FUP/EOS
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Assessment method [11]
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The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). In this OM, percentages of participants with a PGA score of 0 or 1 are reported.
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Timepoint [11]
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Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [12]
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Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 4, 6 and FUP/EOS
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Assessment method [12]
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Four body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD.
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Timepoint [12]
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Baseline, Weeks 1, 2, 4, 6 and FUP/EOS (28-35 days post-last dose)
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Secondary outcome [13]
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Number of Participants With All-Causality Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [13]
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An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device; the event needed not necessarily have a causal relationship with the treatment or usage. TEAEs were events between first dose of study drug and up to discharge from study that were absent before treatment or that worsened relative to pretreatment state. An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect.
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Timepoint [13]
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Day 1 through Week 6
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Secondary outcome [14]
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Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
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Assessment method [14]
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Abnormality in vital signs: increase and decrease of change of supine diastolic blood pressure from baseline >=20 mmHg, supine systolic blood pressure <90 mmHg, and increase in change of supine systolic blood pressure from baseline >=30 mmHg.
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Timepoint [14]
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Day 1 through Week 6
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Secondary outcome [15]
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Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria
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Assessment method [15]
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ECG abnormalities criteria included: value of PR interval >=300 msec, percent change of PR interval >=25/50% and change of corrected QT interval using Fridericia's Formula (QTcF) >=30 msec and <60 msec.
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Timepoint [15]
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Day 1 through Week 6
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Secondary outcome [16]
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Number of Participants With Laboratory Test Abnormalities
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Assessment method [16]
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Laboratory parameters included: hematology (hemoglobin, hematocrit, red blood cell, platelet and white blood cell count, neutrophils, eosinophils, monocytes, basophils and lymphocytes), chemistry (blood urea nitrogen, creatinine, sodium, potassium, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, albumin, total protein and serum pregnancy test [for all female participants]) and urine (urine pregnancy test [for all female participants]).
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Timepoint [16]
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Day 1 through Week 6
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Secondary outcome [17]
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Number of Participants With Different Severity Grades in Skin Tolerability at Day 1, Weeks 1, 2, 4, 6, Early Termination (ET) and FUP
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Assessment method [17]
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The investigator or designee assessed tolerability at the site of investigational product application (pre-dose and immediately post-dose). This assessment focused on the treated non-lesional skin using the scale: none = no evidence of local intolerance; mild = minimal erythema and/or oedema, slight glazed appearance; moderate = definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology; severe (to be reported as an AE) = erythema, oedema glazing with fissures, few vesicles or papules: consider removing topical agent (if still in place); very severe (to be reported as an AE) = strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent (if still in place).
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Timepoint [17]
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Day 1, Weeks 1, 2, 4, 6, ET and FUP (28-35 days post-last dose)
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Eligibility
Key inclusion criteria
- Atopic Dermatitis (AD): Have been diagnosed with AD for at least 3 months; Have an
Investigator's Global Assessment (IGA) score of 2 (mild), or 3 (moderate); Have AD
covering 5% to 20% (inclusive) of BSA.
- Plaque psoriasis: Have been diagnosed with plaque psoriasis (psoriasis vulgaris) for
at least 6 months; Have a Physician Global Assessment (PGA) score of 2 (mild), or 3
(moderate); Having plaque psoriasis covering 5% to 15% (inclusive) of BSA.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Presence of skin comorbidities that would interfere with study assessment or response
to treatment.
- Current or recent history of severe, progressive, or uncontrolled renal, hepatic,
hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or
neurological disease.
- Other medical or psychiatric condition including recent (within the past year) or
active suicidal ideation/behavior or laboratory abnormality that may increase the risk
of study participation or, in the investigator's judgment, make the participant
inappropriate for the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/08/2021
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Sample size
Target
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Accrual to date
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Final
104
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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0
Australian Clinical Research Network - Maroubra
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Recruitment hospital [2]
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Emeritus Research - Camberwell
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Recruitment postcode(s) [1]
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2035 - Maroubra
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Recruitment postcode(s) [2]
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3124 - Camberwell
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Florida
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Indiana
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Michigan
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Country [5]
0
0
United States of America
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State/province [5]
0
0
North Carolina
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Oregon
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Tennessee
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Texas
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Country [9]
0
0
Canada
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State/province [9]
0
0
Ontario
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Country [10]
0
0
Canada
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State/province [10]
0
0
Quebec
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Country [11]
0
0
Poland
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State/province [11]
0
0
Bialystok
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Country [12]
0
0
Poland
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State/province [12]
0
0
Grodzisk Mazowiecki
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Country [13]
0
0
Poland
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State/province [13]
0
0
Katowice
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Country [14]
0
0
Poland
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State/province [14]
0
0
Lodz
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Country [15]
0
0
Poland
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State/province [15]
0
0
Ostrowiec Swietokrzyski
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Country [16]
0
0
Poland
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State/province [16]
0
0
Rzeszow
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Country [17]
0
0
Poland
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State/province [17]
0
0
Warszawa
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is being conducted to provide data on efficacy, safety, tolerability and PK of
PF-07038124 ointment versus vehicle control in the treatment of mild to moderate AD and mild
to moderate plaque psoriasis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04664153
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04664153
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