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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/NCT04378569
Registration number
NCT04378569
Ethics application status
Date submitted
30/04/2020
Date registered
7/05/2020
Date last updated
5/04/2024
Titles & IDs
Public title
Safety and Efficacy of ARQ-252 Cream in Subjects With Chronic Hand Eczema
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Scientific title
A Phase 1/2b, Multiple Dose and 12-Week, Parallel Group, Double Blind, Dose Ranging, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-252 Cream 0.1% and ARQ-252 Cream 0.3% in Subjects With Chronic Hand Eczema
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Secondary ID [1]
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ARQ-252-205
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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:
Chronic Hand Eczema
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Condition category
Condition code
Skin
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ARQ-252 cream 0.3%
Treatment: Drugs - ARQ-252 cream 0.1%
Treatment: Drugs - ARQ-252 Vehicle Cream
Active Comparator: ARQ-252 cream 0.3% QD (once daily) - Active Comparator
Active Comparator: ARQ-252 cream 0.3% BID (twice daily) - Active Comparator
Active Comparator: ARQ-252 cream 0.1% QD (once daily) - Active Comparator
Placebo Comparator: Vehicle cream BID (twice daily) - Placebo Comparator
Placebo Comparator: Vehicle cream QD (once daily) - Placebo Comparator
Treatment: Drugs: ARQ-252 cream 0.3%
ARQ-252 cream 0.3%
Treatment: Drugs: ARQ-252 cream 0.1%
ARQ-252 cream 0.1%
Treatment: Drugs: ARQ-252 Vehicle Cream
ARQ-252 Vehicle Cream
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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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Cohort 1: Number of Participants With =1 Adverse Event (AE)
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Assessment method [1]
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The number of Cohort 1 participants with an AE is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research.
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Timepoint [1]
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Up to 3 weeks
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Primary outcome [2]
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Cohort 1: Number of Participants With an Application Site Reaction
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Assessment method [2]
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The number of Cohort 1 participants with AEs coded as application site events is reported.
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Timepoint [2]
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Up to 3 weeks
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Primary outcome [3]
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Cohort 1: Number of Participants With =1 Serious Adverse Event (SAE)
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Assessment method [3]
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The number of Cohort 1 participants with an SAE is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health.
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Timepoint [3]
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Up to 3 weeks
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Primary outcome [4]
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Cohort 1: Number of Participants With Significant Changes in Hematology Laboratory Parameters
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Assessment method [4]
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The number of Cohort 1 participants with a significant change in hematology is reported.
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Timepoint [4]
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Up to 3 weeks
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Primary outcome [5]
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Cohort 1: Number of Participants With Significant Changes in Chemistry Laboratory Parameters
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Assessment method [5]
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The number of Cohort 1 participants with a significant change in chemistry is reported.
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Timepoint [5]
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Up to 3 weeks
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Primary outcome [6]
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Cohort 2: Investigator's Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 12
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Assessment method [6]
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The IGA is 5-point scale assessing the severity of hand eczema; scores range from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' at Week 12 is presented.
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Timepoint [6]
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Week 12
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Secondary outcome [1]
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Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear' PLUS at Least a 2-point Improvement From Baseline
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Assessment method [1]
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The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with an IGA score of 'clear' or 'almost clear' plus =2-point improvement (ie, decrease) from Baseline is presented.
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Timepoint [1]
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Weeks 2, 4, 8 and 12
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Secondary outcome [2]
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Cohort 2: Achievement of at Least a 2-point Improvement in IGA Score From Baseline
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Assessment method [2]
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The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with =2-point improvement from baseline in IGA score is presented.
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Timepoint [2]
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Weeks 2, 4, 8 and 12
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Secondary outcome [3]
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Cohort 2: Achievement of IGA Score of 'Clear' or 'Almost Clear'
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Assessment method [3]
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The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The number of participants with =2-point improvement from baseline is presented.
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Timepoint [3]
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Weeks 2, 4, and 8
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Secondary outcome [4]
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Cohort 2: Change From Baseline in Investigator's Global Assessment (IGA) Score
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Assessment method [4]
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The IGA is 5-point scale assessing the severity of hand eczema, with scores ranging from 0 ('completely clear') to 4 ('severe'), with higher scores indicating greater severity. The mean change from baseline in IGA score is presented, with lower scores indicating a reduction in symptom severity.
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Timepoint [4]
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Weeks 2, 4, 8, and 12
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Secondary outcome [5]
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Cohort 2: Change From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Score
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Assessment method [5]
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The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours. The mean change from baseline in WI-NRS is reported.
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Timepoint [5]
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Weeks 2, 4, 8, and 12
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Secondary outcome [6]
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Cohort 2: Achievement of =4-point Reduction From Baseline in Worst Itch Numeric Rating Scale (WI-NRS) Pruritus Score
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Assessment method [6]
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The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the subject experienced in the previous 24 hours (higher scores indicate higher itch severity). The mean change from baseline in WI-NRS is reported. The number of participants with a baseline WI-NRS score of =4 who achieved a =4-point reduction is reported.
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Timepoint [6]
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Weeks 2, 4, 8, and 12
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Secondary outcome [7]
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Cohort 2: Change From Baseline in Hand Eczema Severity Index (HECSI) Score
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Assessment method [7]
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The HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) on 5 areas of the hand (fingertips, fingers [except tips], palm, back of hand, wrists) by use of a standard scale. Each subscale is scored from 0 to 60; the total HECSI score ranges from 0 to 360 with higher scores indicating greater symptom severity. The mean change from baseline in HECSI is reported.
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Timepoint [7]
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Weeks 2, 4, 8, and 12
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Secondary outcome [8]
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Cohort 2: Change From Baseline in Numerical Rating Scale (NRS) for Pain Score
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Assessment method [8]
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The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The mean change from baseline NRS Pain score is reported.
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Timepoint [8]
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Weeks 2, 4, 8, and 12
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Secondary outcome [9]
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Cohort 2: The Rate of Achievement of =4-point Reduction From Baseline in Pain Numerical Rating Scale (NRS) Score
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Assessment method [9]
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The NRS Pain Scale is a widely-used instrument for pain screening. Participants rate the intensity of pain experienced in the past 24 hours on a scale from 0 ('no pain at all') to 10 ('worst pain possible'). The number of participants with =4-point reduction from baseline NRS Pain score is reported.
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Timepoint [9]
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Weeks 2, 4, 8, and 12
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Secondary outcome [10]
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Cohort 2: Change From Baseline in Overall Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Score at Each Visit
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Assessment method [10]
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The QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention. The scoring ranges from 0 ('no eczema') to 117 ('most severe eczema').
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Timepoint [10]
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Weeks 2, 4, 8, 12, 13
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Secondary outcome [11]
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Cohort 2: Change From Baseline in Total Body Surface Area (BSA) Affected by Disease
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Assessment method [11]
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The percentage of total body surface area (BSA) affected by chronic hand eczema (CHE) is a measure of the area of the subject's hands that is affected by CHE lesions, expressed as a percentage of total BSA. Based on the subject's hand method, the BSA of 1 side of 1 hand is assumed to be 1% of total BSA. The surface area of lesions on both sides of both hands are added to calculate the total BSA affected by CHE. The total BSA affected by CHE ranges from 0% (no CHE lesions) to 4% (the entire front and back sides of both hands are affected by CHE lesions).
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Timepoint [11]
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Weeks 2, 4, 8, 12
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Eligibility
Key inclusion criteria
Inclusion Criteria
- Participants legally competent to sign and give informed consent.
- Males and females 18 years of age and older (inclusive) at the time of consent.
- Clinical diagnosis of chronic hand eczema, defined as hand eczema persistent for more
than 3 months, or returned twice or more within the last 12 months. Generally stable
disease for 6 weeks.
- Chronic hand eczema involving at least 0.3% body surface area total (i.e.,
approximately a third of one handprint) lesions on both hands added together
- Female subjects of childbearing potential (FOCBP) must have a negative serum pregnancy
test at Screening and negative urine pregnancy test at Baseline. For FOCBP involved in
any sexual intercourse that could lead to pregnancy: the subject must agree to use a
highly effective contraceptive method for at least 4 weeks prior to Day 1.
Additionally, from Day 1 until at least 4 weeks after the last investigational product
administration, these subjects must agree to use at least 1 highly effective
contraceptive method in addition to 1 barrier method according to the Contraception
Requirements Section of the protocol.
- Females of non-childbearing potential must either be post-menopausal with spontaneous
amenorrhea for at least 12 months or have undergone surgical sterilization.
- Males, if engaging in sexual intercourse with a female who is pregnant or a female of
childbearing potential, must agree to use a condom every time during the study and
every and every time subsequently until 4 weeks after the last dose of investigational
product.
- Subjects in good health as judged by the Investigator, based on medical history,
physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs,
hematology values, and urinalysis.
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Minimum age
18
Years
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Maximum age
No limit
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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
Exclusion Criteria
- Concurrent skin diseases on the hands which, in the opinion of the Investigator, could
confound the study (e.g., tinnea manuum).
- Subjects with any presence or history of psoriasis.
- History of a positive patch test with continued exposure to allergen. Subjects must
have undergone diagnostic patch testing within 3 years prior to Baseline (Visit 2).
- Subjects who cannot discontinue systemic and/or topical therapies for the treatment of
chronic hand eczema prior to Baseline and during the study
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to
Baseline
- Pregnant or lactating women or women planning to become pregnant during the study and
/ or within 28 days following the last dose of investigational product.
- Subjects with any serious medical condition or clinically significant laboratory, ECG,
vital signs or physical examination abnormality that would prevent study participation
or place the subject at significant risk, as judged by the Investigator.
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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 analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/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
20/04/2020
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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
24/02/2021
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Sample size
Target
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Accrual to date
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Final
230
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Arcutis Clinical Site 306 - Westmead
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Recruitment hospital [2]
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Arcutis Clinical Site 303 - East Melbourne
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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United States of America
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State/province [6]
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Maryland
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Country [7]
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Minnesota
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United States of America
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State/province [9]
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New York
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United States of America
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State/province [10]
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North Carolina
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Oregon
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State/province [12]
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Pennsylvania
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Texas
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Country [14]
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State/province [14]
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Virginia
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Country [15]
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Canada
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State/province [15]
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British Columbia
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Country [16]
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Canada
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State/province [16]
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Ontario
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Canada
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State/province [17]
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Montreal
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arcutis Biotherapeutics, Inc.
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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 will assess the safety and efficacy of ARQ-252 cream in subjects with chronic hand
eczema
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04378569
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Berk, MD
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Address
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Arcutis Biotherapeutics, Inc.
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04378569
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