Papular-pustular Rosacea Clinical Trial
Official title:
Evaluation of the Efficacy of Isotretinoin Versus Placebo in Terms of Response Rate Among Patients Presenting Papular-pustular Rosacea Resistant to Standard Therapy
A national, multicentre, prospective, randomised, double-blind, phase III study in 2
parallel groups of isotretinoin versus placebo in patients presenting papular-pustular
rosacea resistant to standard therapy. A non-balanced group (2 isotretinoin /1 placebo)
design was selected since, given the nature of the study disease, fewer patients will
receive the placebo than active isotretinoin.
Treatment duration for each patient : 4 months, with monthly evaluation Follow-up at 2
months and 4 months for patients responsive after 4 months of treatment.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment