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A Randomized-Controlled Trial of Oral Low-Dose Isotretinoin for Difficult-To-Treat Papulopustular Rosacea.

J Invest Dermatol. 2016 Feb 5;

Authors: Sbidian E, Vicaut É, Chidiack H, Anselin E, Cribier B, Dréno B, Chosidow O

Abstract
Rosacea is a chronic inflammatory facial skin disease with psychosocial impact. Oral cyclines are recommended for moderate-to-severe papulopustular rosacea. Oral isotretinoin was found valuable for difficult-to-treat cases in several reports. This multicenter, double-blind, randomized-placebo-controlled trial compared oral isotretinoin (0.25 mg/kg/day) to placebo (2:1 ratio) for difficult-to-treat papulopustular rosacea. Included patients had at least 8 papulopustular lesions. The primary endpoint after the 4-month-treatment period was the response rate: at least 90% reduction of the number of papules/pustules compared to baseline. Secondary outcomes included measures on quality of life (Skindex score). Between February 2007 and August 2009, 156 patients were randomized to receive either isotretinoin (n=108) or placebo (n=48). In the intention-to-treat population, 57.4% of isotretinoin recipients reached the primary endpoint, compared to 10.4% of those taking the placebo (absolute difference, 47 percentage points; 95% confidence interval (CI), 34.3-59.7; P<0.0001). To consider therapy successful, 2.1 (95% CI 1.7-2.9) patients had to be treated. Skindex scores had improved significantly more for isotretinoin- than placebo-treated patients. Rosacea relapsed in 27 (58.3%) out of 51 patients who accepted 4 months of continued follow-up, with a median of 15 weeks to recurrence. The percentages of patients in each arm who stopped their treatment because of adverse event(s) did not differ. Low-dose isotretinoin was an effective therapeutic option for difficult-to-treat papulopustular rosacea. Further studies should investigate the value of a minimal effective isotretinoin dose to maintain these remissions.

PMID: 26854486 [PubMed - as supplied by publisher]

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