Recruiting

Phase 2

PR022Efficacy and Safety of PR022 Topical Gel to Treat Mild-to-Moderate Atopic Dermatitis

Sponsor:

Realm Therapeutics, Inc.

Code:

NCT03351777

Conditions

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

PR022

Study Details

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).

Conditions

Atopic Dermatitis

Study ID

NCT03351777

Start date

Dec 4, 2017

Status verified date

Dec, 2017

Completion date

Jul, 2018

Anticipated

Primary completion date

Apr, 2018

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PR022 topical gel, 0.05%

Applied twice daily for 28 days

experimental: PR022 topical gel, 0.1%

Applied twice daily for 28 days

placebo comparator: PR022 topical gel vehicle

Applied twice daily for 28 days

Interventions

PR022

Topical Gel

Primary outcome measure

Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI) [ Time Frame: 29 days ]

Central Contacts and Locations

Central contacts

Valerie Crossley

4843212700 Valerie@realmtx.com

Kathy Goin

kgoin@realmtx.com

Locations

Principal Investigator

Recruiting

Philadelphia, Pennsylvania, United States, 19148

More Information

Sponsor

Realm Therapeutics, Inc.

Last update posted

Dec 21, 2017

Last verified

Dec, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Realm Therapeutics, Inc. on 2017-12-21.