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Combination Therapy with Adapalenebenzoyl Peroxide And BJD THERAPEUTICS British Journal of Dermatology 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 B. Dre´no, R. Kaufmann,* S. Talarico, V. Torres Lozada,à M.A. Rodrı´guez-Castellanos,§ M. Go´mez-Flores,– J. De Maubeuge,** M. Berg, P. Foley,àà A. Sysa-Jedrzejowska,§§ N. Kerrouche,–– F. Paliargues–– and V. Bettoli*** Hoˆpital Hotel Dieu, Department of Dermato-Oncology, Place Alexis-Ricordeau, 44093 Nantes Cedex 1, France *Department of Dermatology, Goethe-University Hospital, Frankfurt am Main, Germany UNIFESP – Universidade Federal de Sa˜o Paulo, Sa˜o Paulo, Brazil àDepartment of Dermatology, Jua´rez Hospital, Mexico City, Mexico §Instituto Dermatolo´gico de Jalisco, Zapopan, Mexico –University Hospital ‘Dr Jose´ Eleuterio Gonza´lez’, Monterrey, Mexico **CHU Saint-Pierre, Universite´ Libre de Bruxelles, Brussels, Belgium Department of Dermatology So¨rmland, Ma¨lar Hospital, Eskilstuna, Sweden ààSkin and Cancer Foundation Inc., Carlton, and the University of Melbourne, Parkville, Victoria, Australia §§Department of Dermatology, Central Clinical Hospital of Medical University of Lodz, Poland ––Galderma R&D, Sophia-Antipolis, France ***Clinica Dermatologica, Azienda Ospedaliera Arcispedale S. Anna Universita` di Ferrara, Ferrara, Italy Summary Correspondence Background Oral antibiotics in association with a topical retinoid with or without Brigitte Dre´no. benzoyl peroxide (BPO) are the recommended first-line option in the treatment E-mail: [email protected] of moderate to severe acne vulgaris. Objectives To evaluate the efficacy and safety of oral lymecycline 300 mg with Accepted for publication 5 April 2011 adapalene 0Æ1%–BPO 2Æ5% (A ⁄BPO) fixed-dose gel in comparison with oral lymecycline 300 mg with a vehicle gel in subjects with moderate to severe acne Funding sources vulgaris. This study was supported by Galderma. 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 Conflicts of interest 12 weeks. Evaluations included percentage changes from baseline in lesion All investigators received fees for conducting this study. N.K. and F.P. are current employees of counts, success rate (subjects ‘clear’ or ‘almost clear’), skin tolerability, adverse Galderma R&D. events and patients’ satisfaction. Results The median percentage reduction from baseline in total lesion counts at DOI 10.1111/j.1365-2133.2011.10374.x week 12 was significantly higher (P <0Æ001) in the lymecycline with A ⁄BPO group ()74Æ1%) than in the lymecycline with vehicle group ()56Æ8%). The suc- cess rate was significantly higher (47Æ6% vs. 33Æ7%, P =0Æ002) in subjects trea- ted with lymecycline and A ⁄BPO. Both inflammatory and noninflammatory lesions were significantly reduced at week 12 (both P <0Æ001) with a rapid onset of action from week 2 for noninflammatory lesions (P<0Æ001) and week 4 for inflammatory lesions (P=0Æ005). The A ⁄BPO and lymecycline combin- ation 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=0Æ031). Conclusion These results demonstrate the clinical benefit of combining A ⁄BPO with lymecycline in the treatment of moderate to severe acne vulgaris. Ó 2011 The Authors BJD Ó 2011 British Association of Dermatologists 2011 165, pp383–390 383 384 Adapalene-BPO gel with oral lymecycline in acne vulgaris, B. Dre´no et al. The combination of a topical retinoid and an antimicrobial conducted in 2009 at 32 investigational centres in nine coun- agent is considered to be the preferred approach for almost all tries worldwide (France, Italy, Belgium, Sweden, Germany, patients with acne vulgaris except the most severe cases.1 Poland, Mexico, Brazil and Australia). Enrolled subjects were Among various fixed-dose combinations, the once-daily gel of any race or either sex, aged between 12 and 35 years, with containing the topical retinoid adapalene 0Æ1% and the anti- moderate or severe acne vulgaris as defined by the Investiga- microbial benzoyl peroxide 2Æ5% (A ⁄BPO) has shown its tor’s Global Assessment (IGA; score of 3 or 4 on a scale from benefit in several double-blind, randomized and controlled 0 to 5). Eligible subjects were required to have a minimum of trials. Compared with the adapalene and BPO monotherapies, 20 inflammatory lesions, between 30 and 120 noninflamma- A ⁄BPO when applied once daily for 12 weeks significantly tory lesions, and no more than three nodulocystic lesions on reduced the number of both inflammatory and noninflamma- the face excluding the nose area. Subjects with acne conglobata, tory lesions in subjects with moderate acne, with a rapid onset acne fulminans (secondary acne) or other dermatological of action and a good safety profile.2–4 The effect of A ⁄BPO conditions which could interfere with treatment or evaluation was sustained for 4 months, and it was also safe as a long- were excluded. All female subjects of childbearing potential term treatment for up to 12 months.5 had to have a negative urine pregnancy test before and during Tetracyclines are a historically conventional treatment of the study. The study protocol was approved by the local ethics acne vulgaris and more particularly in papulopustular acne not committees and the study was conducted in accordance with amenable to topical therapy. Tetracyclines function by inhibit- Good Clinical Practice. All subjects provided written informed ing bacterial multiplication and growth and also possess anti- consent before entering the study. inflammatory properties.6 Second-generation tetracyclines such as lymecycline, minocycline and doxycycline are preferred Treatment administered because of improved oral absorption, enhanced tissue penetra- tion and slower elimination than first-generation tetra- Subjects were randomized in a 1 : 1 ratio by a designated stat- cyclines.7 Furthermore, the efficacy of lymecycline has been istician (using a computed randomization list that generated demonstrated to be similar to that of minocycline in multicen- treatment numbers in a block size of four) to receive either tre, double-blind, randomized and controlled studies, with oral lymecycline with A ⁄BPO gel (EpiduoÒ; Galderma SA, fewer treatment-related adverse events (AEs), and to be more Lausanne, Switzerland) or lymecycline (TetralysalÒ; Galderma) cost-effective.8,9 Thus, lymecycline may be regarded as a suit- with a vehicle gel. Oral lymecycline 300 mg was to be taken able first-line oral treatment for acne vulgaris. once daily in the morning, and A ⁄BPO or its vehicle was to While isotretinoin is reserved for the most severe cases of be topically applied on the whole face, once daily in the even- acne, few options are available for the treatment of moderate ing for 12 weeks. The randomization list and the electronic to severe acne. Combination therapy including agents of dis- file were secured in a locked cabinet and in an electronic file tinct and complementary modes of action may enhance treat- with restricted access to only the designated personnel directly ment efficacy and is recommended in several international responsible for labelling and handling the study medications, consensus guidelines.1,7,10 A previous clinical trial clearly until the study database was locked and ready to be unblinded demonstrated that lymecycline 300 mg daily plus adapalene for statistical analyses. The investigators could not access the gel 0Æ1% combination treatment resulted in a significantly randomization list. greater mean decrease in the number of inflammatory, non- In addition, use of the provided gentle skin cleanser at least inflammatory and total lesions than lymecycline plus vehicle prior to applying the study medication, and moisturizing in the treatment of moderate to moderately severe acne vulga- lotion in the morning for symptomatic relief of skin dry- ris.11 More recently, a double-blind, randomized, controlled ness ⁄irritation was encouraged. A sun-protection factor (SPF) study demonstrated the superior efficacy of a combination 50 sunscreen was also provided and recommended for used in treatment using oral doxycycline 100 mg and A ⁄BPO com- case of outdoor activities. Integrity of the blinding was pared with doxycycline and vehicle in the treatment of severe ensured by packaging the topical medication in identical tubes acne vulgaris.12 The aim of the present study was to evaluate and requiring a third party other than the investigator ⁄evalua- the efficacy and safety of oral lymecycline with A ⁄BPO gel tor to dispense the medications. compared with oral lymecycline with vehicle in the treatment of moderate to severe acne vulgaris. Study assessments and outcomes Materials and methods Efficacy and safety assessments were performed at baseline and at weeks 2, 4, 8 and 12. Efficacy variables were the percentage change from baseline in inflammatory, noninflammatory and Study design total lesion counts (sum of inflammatory and noninflammatory This double-blind, randomized, controlled, parallel group trial lesions), the total lesion improvement assessed by the Kligman (EudraCT number: 2008-006792-68) was performed to com- score (poor, fair, good, excellent), and the success rate pare the efficacy and safety of lymecycline 300 mg in combin- defined as the percentage of subjects with an IGA score of 0 ation with either A ⁄BPO or its vehicle. The study
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