title: A Randomized-Controlled Trial of Oral Low-Dose Isotretinoin for Difficult-To-Treat Papulopustular Rosacea.
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) with placebo (2:1 ratio) for difficult-to-treat papulopustular rosacea. Included patients had at least eight 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 with 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 with 10.4% of those taking the placebo (absolute difference, 47 percentage points; 95% confidence interval, 34.3-59.7; P < 0.0001). To consider therapy successful, 2.1 (95% confidence interval 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%) 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.
authors: Department of Dermatology, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Henri-Mondor, Université Paris-Est Créteil-Val de Marne, EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques) and INSERM, Centre d'Investigation Clinique (CIC), Créteil, France.
authors: Emilie
authors: E
authors: Sbidian
authors: Unité de Recherche Clinique, APHP, Hôpital Fernand-Vidal, Université René-Diderot, Paris, France.
authors: Éric
authors: É
authors: Vicaut
authors: Laboratoire Bailleul, Paris, France.
authors: Henri
authors: H
authors: Chidiack
authors: Laboratoire Bailleul, Paris, France.
authors: Elie
authors: E
authors: Anselin
authors: Department of Dermatology, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France.
authors: Bernard
authors: B
authors: Cribier
authors: Department of Dermato-oncology, Hôtel-Dieu, Université Nantes, Nantes, France.
authors: Brigitte
authors: B
authors: Dréno
authors: Department of Dermatology, Assistance Publique-Hôpitaux de Paris (APHP), Hôpital Henri-Mondor, Université Paris-Est Créteil-Val de Marne, EpiDermE (Epidémiologie en Dermatologie et Evaluation des Thérapeutiques) and INSERM, Centre d'Investigation Clinique (CIC), Créteil, France. Electronic address: olivier.chosidow@aphp.fr.
authors: Olivier
authors: O
authors: Chosidow
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D015474:Isotretinoin / Q000009:adverse effects / Q000627:therapeutic use*; D007641:Keratolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D018579:Patient Selection; D018570:Risk Assessment; D012393:Rosacea / Q000188:drug therapy* / Q000473:pathology*; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007641:Keratolytic Agents; D015474:Isotretinoin