Rosacea
Conditions
Brief 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.
Interventions
DRUGDRM02
OTHERVehicle
Sponsors
Dermira, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in inflammatory lesion count | Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Investigator's Global Evaluation (IGE) | From baseline to weeks 0, 1, 2, 3, 4 and 6 |
| IGE dichotomized into success and failure | Week 6 |
| Percent change in inflammatory lesions | Week 6 |
Other
| Measure | Time frame |
|---|---|
| Rosacea Signs and Symptoms (RSS) | From baseline to weeks 0, 1, 2, 3, 4 and 6 |
Countries
Canada
Outcome results
None listed