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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Windsor Clinical Research, Inc.
Windsor, Ontario, Canada
Clinique Médicale Dr Isabelle Delorme
Drummondville, Quebec, Canada
Innovaderm Research, Inc
Montreal, Quebec, Canada
Change in inflammatory lesion count
Time frame: Week 6
Investigator's Global Evaluation (IGE)
Time frame: From baseline to weeks 0, 1, 2, 3, 4 and 6
IGE dichotomized into "success" and "failure"
Time frame: Week 6
Percent change in inflammatory lesions
Time frame: Week 6
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