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

Realm Therapeutics

Status and phase: Unknown; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: PR022

Study type: Interventional

Funder types: Industry

Identifiers

NCT03351777

REALM-1

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

PR022 topical gel, 0.05%

Experimental group

Description:

Applied twice daily for 28 days

Treatment:

Drug: PR022

PR022 topical gel, 0.1%

Experimental group

Description:

Applied twice daily for 28 days

Treatment:

Drug: PR022

PR022 topical gel vehicle

Placebo Comparator group

Description:

Applied twice daily for 28 days

Treatment:

Drug: PR022