NCT01993446

A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (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 rosacea when applied twice daily for 6 weeks.

Detailed description

This is a double-blind, randomized, vehicle controlled, study enrolling 30 subjects with rosacea 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 inflammatory lesion counts, the Investigator's Global Evaluation (IGE) and the Rosacea Signs and Symptoms (RSS) scale.

Conditions

• Rosacea

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

3 sites across 1 country: Canada