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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03351777
• Other study ID #: REALM-1
• Status: Recruiting
• Phase: Phase 2
• First received: November 20, 2017
• Last updated: December 19, 2017
• Start date: December 4, 2017
• Est. completion date: July 2018

Study information

• Verified date: December 2017
• Source: Realm Therapeutics, Inc.
• Contact: Valerie Crossley
• Phone: 4843212700
• Email: Valerie[@]realmtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PR022
Topical Gel

Locations

Country	Name	City	State
United States	Principal Investigator	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Realm Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in serum IgE titer and TARC concentration from Baseline to Day 29		29 days
Primary	Percent change from Baseline to Day 29 in Eczema Area and Severity Index (EASI)		29 days
Secondary	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
Secondary	Percentage of subjects with an ISGA score of "Clear" (0) or "Almost Clear" (1) at Day 29		29 Days
Secondary	Percentage of subjects with EASI-75 (= 75% improvement from Baseline) at Day 29		29 Days
Secondary	Percentage of subjects with EASI-50 (= 50% improvement from Baseline) at Day 29		29 Days
Secondary	Percent change from Baseline to Day 29 in body surface area (BSA) affected by AD		29 Days
Secondary	Change from Baseline to Day 29 in SCORing Atopic Dermatitis (SCORAD)		29 Days
Secondary	Percent change from Baseline to Day 29 in pruritus Numerical Rating Scale (NRS)		29 Days
Secondary	Change from Baseline to Day 29 in 5 dimensions of itch (5-D Itch) scale		29 days
Secondary	Change from Baseline to Day 29 in Dermatology Life Quality Index (DLQI)		29 days
Secondary	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