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A randomized controlled study to evaluate isotretinoin versus doxycycline in the treatment of rosacea subtypes II and III

A double-blind, randomized, placebo-controlled, five-arm, multicenter study in 573 rosacea patients evaluated the effects of oral isotretinoin (0.1, 0.3 or 0.5 mg/kg) with doxycycline (50-100 mg/day) or placebo. The primary endpoint was the decrease in the total sum of facial papules and pustules/nodules after 12 weeks. After an interim analysis of approximately 45 patients/group, the optimal dose of isotretinoin was found to be 0.3 mg/kg (P < 0.005 vs. placebo). In the second part of the study 0.3 mg/kg isotretinoin was compared with doxycycline and the other study arms closed. Isotretinoin was statistically noninferior to doxycycline (P < 0.001), effecting a 90% decrease in lesions compared with 83% after doxycycline. Complete remission ...