The purpose of this study is to determine whether DRM02 is safe and effective in the treatment of plaque psoriasis when applied twice daily for 6 weeks.
This is a double-blind, randomized, within-subject control, study enrolling 20 subjects with plaque psoriasis 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 the Physician's Lesion Assessment (PLA) and the Severity of Psoriasis Area Severity Index (PASI) from only the two plaques identified at the baseline visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
Clinique Médicale Dr Isabelle Delorme
Drummondville, Quebec, Canada
Innovaderm Research, Inc
Montreal, Quebec, Canada
Change in Physician's Lesion Assessment
Time frame: Week 6
Physician's Lesion Assessment
Time frame: From baseline to weeks 0, 1, 2, 3, 4 and 6
PLA dichotomized into "success" and "failure"
Time frame: Week 6
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