title: 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.
abstract: 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.
  
  
  OBJECTIVE
  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).
  
  
  CONCLUSIONS
  These results demonstrate the clinical benefit of combining A/BPO with lymecycline in the treatment of moderate to severe acne vulgaris.
authors.affiliation: Hôpital Hotel Dieu, Department of Dermato-Oncology, Place Alexis-Ricordeau, 44093 Nantes Cedex 1, France. brigitte.dreno@wanadoo.fr
authors.forename: B
authors.initials: B
authors.lastname: Dréno
authors.forename: R
authors.initials: R
authors.lastname: Kaufmann
authors.forename: S
authors.initials: S
authors.lastname: Talarico
authors.forename: V
authors.initials: V
authors.lastname: Torres Lozada
authors.forename: M A
authors.initials: MA
authors.lastname: Rodríguez-Castellanos
authors.forename: M
authors.initials: M
authors.lastname: Gómez-Flores
authors.forename: J
authors.initials: J
authors.lastname: De Maubeuge
authors.forename: M
authors.initials: M
authors.lastname: Berg
authors.forename: P
authors.initials: P
authors.lastname: Foley
authors.forename: A
authors.initials: A
authors.lastname: Sysa-Jedrzejowska
authors.forename: N
authors.initials: N
authors.lastname: Kerrouche
authors.forename: F
authors.initials: F
authors.lastname: Paliargues
authors.forename: V
authors.initials: V
authors.lastname: Bettoli
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000068816:Adapalene; D000284:Administration, Oral; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001585:Benzoyl Peroxide / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005782:Gels; D006801:Humans; D008194:Lymecycline / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D017060:Patient Satisfaction; D014677:Pharmaceutical Vehicles; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D005782:Gels; D009281:Naphthalenes; D014677:Pharmaceutical Vehicles; D000068816:Adapalene; D008194:Lymecycline; D001585:Benzoyl Peroxide