A Safety and Efficacy Study of DRM02 in Subjects With Rosacea

• 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 rosacea 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 rosacea with a score of 2 or 3 on the Investigator's Global Evaluation (IGE) of Rosacea scale and at least 15 and not more than 40 papules.

• Subjects willing to minimize external factors that might trigger rosacea flare-ups.

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

• Signed informed consent.

Exclusion Criteria:

• Severe self-reported facial sensitivity.

• Severe sun sensitivity.

• Ocular-only, phymatous rosacea or steroid rosacea.

• Use of topical rosacea treatments in the 4 weeks prior to baseline.

• Use of systemic corticosteroids within the 4 weeks prior to baseline.

• Use of systemic antibiotics in the 4 weeks prior to baseline.

• Use of systemic retinoids for in the 6 months prior to baseline.

• Use of topical retinoids in the 3 months prior to baseline.

• Use of light- or laser-based rosacea treatments in the past 2 months prior to baseline.

• Cosmetic procedures within the 2 months prior to baseline.

• Use of topical anti-aging medications in the 2 weeks prior to baseline.

• Subjects who have poor skin condition within 5 cm of the treatment area.

• Subjects who are current drug or alcohol abusers; have a history of immunodeficiency 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.