Status:
UNKNOWN
Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis
Lead Sponsor:
Realm Therapeutics, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03351777
Start Date
December 4 2017
End Date
July 1 2018
Last Update
December 21 2017
Active Locations (1)
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1
Principal Investigator
Philadelphia, Pennsylvania, United States, 19148