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

• Status: Unknown status
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Realm Therapeutics, Inc.

Criteria

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