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

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.GaldermaGalderma RDHop Hotel Dieu, Dept Dermatooncol, F-44093 Nantes 1, FranceGoethe Univ Hosp, Dept Dermatol, Frankfurt, GermanyUNIFESP Universidade Federal de São Paulo, São Paulo, BrazilJuarez Hosp, Dept Dermatol, Mexico City, DF, MexicoInst Dermatol Jalisco, Zapopan, MexicoUniv Hosp Dr Jose Eleuterio Gonzalez, Monterrey, MexicoUniv Libre Bruxelles, CHU St Pierre, Brussels, BelgiumMalar Hosp, Dept Dermatol Sormland, Eskilstuna, SwedenSkin & Canc Fdn Inc, Carlton, Vic, AustraliaUniv Melbourne, Parkville, Vic 3052, AustraliaMed Univ Lodz, Cent Clin Hosp, Dept Dermatol, Lodz, PolandGalderma R&D, Sophia Antipolis, FranceAzienda Osped Arcispedale S Anna Univ Ferrara, Dermatol Clin, Ferrara, ItalyUNIFESP Universidade Federal de São Paulo, São Paulo, BrazilWeb of Scienc