Rosacea Clinical Trial
Official title:
A Randomized, Double-blind, Vehicle Controlled Study of the Safety and Efficacy of Topical DRM02 in Subjects With Rosacea
NCT number | NCT01993446 |
Other study ID # | DRM02-ROS02 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | October 2013 |
Est. completion date | March 2014 |
Verified date | July 2021 |
Source | Eli Lilly and Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Clinique Médicale Dr Isabelle Delorme | Drummondville | Quebec |
Canada | Innovaderm Research, Inc | Montreal | Quebec |
Canada | Windsor Clinical Research, Inc. | Windsor | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dermira, Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rosacea Signs and Symptoms (RSS) | From baseline to weeks 0, 1, 2, 3, 4 and 6 | ||
Primary | Change in inflammatory lesion count | Week 6 | ||
Secondary | Investigator's Global Evaluation (IGE) | From baseline to weeks 0, 1, 2, 3, 4 and 6 | ||
Secondary | IGE dichotomized into "success" and "failure" | Week 6 | ||
Secondary | Percent change in inflammatory lesions | Week 6 |
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