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.