Atopic Dermatitis
Conditions
Brief summary
The purpose of this study is to determine whether PR022 Topical Gels are safe and effective treatments for mild-to-moderate atopic dermatitis (AD).
Interventions
DRUGPR022
Topical Gel
Sponsors
Realm Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI) | 29 days |
Secondary
| Measure | 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 |
| 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 |
| Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD) | 29 Days |
Other
| Measure | Time frame |
|---|---|
| Change in serum IgE titer and TARC concentration from Baseline to Day 29 | 29 days |
Countries
United States
Contacts
Primary ContactValerie Crossley
Backup ContactKathy Goin
Outcome results
None listed