Combination therapy with adapalene-benzoyl peroxide and oral lymecycline in the treatment of moderate to severe acne vulgaris: a multicentre, randomized, double-blind controlled study.

Author(s): Dreno B, Kaufmann R, Talarico S, Torres Lozada V, Rodriguez-Castellanos MA, Gomez-Flores M, De Maubeuge J, Berg M, Foley P, Sysa-Jedrzejowska A, Kerrouche N, Paliargues F, Bettoli V

Affiliation(s): Hopital Hotel Dieu, Department of Dermato-Oncology, Place Alexis-Ricordeau, 44093 Nantes Cedex 1, France. brigitte.dreno@wanadoo.fr

Publication date & source: 2011-08, Br J Dermatol., 165(2):383-90. Epub 2011 Jul 6.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

BACKGROUND: Oral antibiotics in association with a topical retinoid with or without benzoyl peroxide (BPO) are the recommended first-line option in the treatment of moderate to severe acne vulgaris. OBJECTIVES: To evaluate the efficacy and safety of oral lymecycline 300 mg with adapalene 0.1%-BPO 2.5% (A/BPO) fixed-dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne vulgaris. METHODS: A total of 378 subjects were randomized in a double-blind, controlled trial to receive once-daily lymecycline with either A/BPO or vehicle for 12 weeks. Evaluations included percentage changes from baseline in lesion counts, success rate (subjects 'clear' or 'almost clear'), skin tolerability, adverse events and patients' satisfaction. RESULTS: The median percentage reduction from baseline in total lesion counts at week 12 was significantly higher (P < 0.001) in the lymecycline with A/BPO group (-74.1%) than in the lymecycline with vehicle group (-56.8%). The success rate was significantly higher (47.6% vs. 33.7%, P = 0.002) in subjects treated with lymecycline and A/BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P < 0.001) with a rapid onset of action from week 2 for noninflammatory lesions (P < 0.001) and week 4 for inflammatory lesions (P = 0.005). The A/BPO and lymecycline combination was well tolerated. The proportion of satisfied and very satisfied subjects was similar in both groups, but the number in the A/BPO group who were 'very satisfied' was significantly greater (P = 0.031). CONCLUSION: These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists 2011.