Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).

Official Title
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Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: PR022


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects 18 to 65 years of age EASI score ≤ 21 at baseline Diagnosis of mild-to-moderate (grade 2 or 3) AD according to the ISGA scale at Baseline BSA affected by AD: 5% to 20% at start of treatment Willing and able to apply study treatments as directed, comply with study instructions, and commit to attending all visits Willing and able to provide informed consent Use of adequate birth control, if of reproductive potential and sexually active Exclusion Criteria: Widespread AD requiring systemic therapy Use of any of the following treatments within the specified time periods prior to Day 1 Topical medications (topical antibiotics, topical corticosteroids, topical antifungals, topical antihistamines, topical retinoids, topical calcipotriene, tacrolimus, pimecrolimus, or other topical drug products for treatment of AD) or bleach bath within 2 weeks prior to Day 1 Systemic agents (cyclosporine, systemic corticosteroids [oral and injectable; intranasal and inhaled corticosteroids are allowed if use is kept constant during the study], systemic antibiotics, immunomodulators or immunosuppressive therapies, interferon, cytotoxic drugs [e.g., methotrexate, cyclophosphamide, azathioprine], oral retinoids, systemic antifungals, tacrolimus) for the treatment of AD within 4 weeks prior to Day 1 Ultraviolet (UV) therapy or use of a tanning booth/parlor within 6 weeks prior to Day 1 Biologic therapies within 12 weeks (or 5 half-lives) prior to Day 1 Antihistamines within 5 days prior to Day 1 [stable regimens (consistent use ≥ 14 days before Day 1) of oral H1 antihistamines for non-AD lesion treatment will be allowed] Active or potentially recurrent dermatologic condition other than AD that may confound evaluation Congenital ichthyosis (note that subjects with ichthyosis vulgaris are permitted) Known allergy to any ingredients of the investigational product formulation Significant confounding conditions as assessed by Investigator Any condition that could interfere with any evaluation in the study Pregnancy or breast feeding Any reason which, in the opinion of the Investigator, interferes with the ability of the subject to participate in or complete the trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PR022 topical gel, 0.05%<br>Applied twice daily for 28 days | Drug: PR022<br>* Topical Gel<br>|
| Experimental: PR022 topical gel, 0.1%<br>Applied twice daily for 28 days | Drug: PR022<br>* Topical Gel<br>|
| Placebo Comparator: PR022 topical gel vehicle<br>Applied twice daily for 28 days | Drug: PR022<br>* Topical Gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI) |  | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects who achieved success in Investigator's Static Global Assessment (ISGA), defined as a score of Clear (0) or Almost Clear (1) with a minimum 2-grade improvement at Day 29 |  | 29 Days | 
| Percentage of subjects with an ISGA score of Clear (0) or Almost Clear (1) at Day 29 |  | 29 Days | 
| Percentage of subjects with EASI-75 (≥ 75% improvement from Baseline) at Day 29 |  | 29 Days | 
| Percentage of subjects with EASI-50 (≥ 50% improvement from Baseline) at Day 29 |  | 29 Days | 
| Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD |  | 29 Days | 
| Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD) |  | 29 Days | 
| Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS) |  | 29 Days | 
| Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale |  | 29 days | 
| Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI) |  | 29 days | 
| Frequency counts and percentages of DLQI scores (scored 0 to 3) at Baseline and Day 29, as well as shift in DLQI scores from Baseline to Day 29 |  | 29 Days |