A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of atopic dermatitis when applied twice daily for 6 weeks.

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

Details

• Lead Sponsor: Dermira, Inc.

Criteria

Inclusion Criteria:

• Male or female 18 to 70 years of age.

• Clinical diagnosis of stable atopic dermatitis (AD) and with two lesions of similar size and have an identical score of at least 5 but no more than 9 on the sum of the individual components of the Eczema Area and Severity Index (EASI) at the Target Lesion scale.

• Male or non-pregnant, non-lactating females.

• Signed informed consent.

Exclusion Criteria:

• Subjects who have unstable atopic dermatitis (AD).

• Significant infection at the target lesion site.

• Prior or concomitant use of systemic therapies for AD within the past 4 weeks. - Prior or concomitant use of topical treatments for AD, to within 10 cm of the target lesion within the past 4 weeks.

• Prior or concomitant use of oral retinoids for AD within the last 6 months.

• Use of biologics for AD within the past 3 months, or 5 half-lives (whichever is longer).

• Subjects who have poor skin condition within 5 cm of the target lesion.

• Subjects who are current drug or alcohol abusers; have a history of immunodeficiency disease; or are a poor medical risk because of other systemic diseases or active uncontrolled infections.

• Subjects with an unstable medical condition or a medical condition not adequately controlled with standard medical therapy.

• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days.

• Subjects who have a clinically significant laboratory value at screening.