NCT01993420

A Safety and Efficacy of DRM02 in Subjects With Atopic Dermatitis

A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Dermira, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with atopic dermatitis and designed to assess the safety, tolerability, and preliminary efficacy of DRM02. Safety will be assessed during the study, through adverse events, local skin responses, urinalysis, serum chemistry and hematology laboratory testing, physical examination and vital signs. Preliminary efficacy will be assessed through the Physician's Lesion Assessment (PLA) and the Eczema Area and Severity Index (EASI) from only the two lesions identified at the baseline visit.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	DRM02
OTHER	Vehicle

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-01
• Completion: 2014-03-01
• First posted: 2013-11-25
• Last updated: 2021-07-20

Locations

2 sites across 1 country: Canada