title: Multicenter study for efficacy and safety evaluation of a fixeddose combination gel with adapalen 0.1% and benzoyl peroxide 2.5% (Epiduo® for the treatment of acne vulgaris in Brazilian population.
abstract: BACKGROUND
  The current options for the treatment of acne vulgaris present many mechanisms of action. For several times, dermatologists try topical agents combinations, looking for better results.
  
  
  OBJECTIVE
  To evaluate the efficacy, tolerability and safety of a topical, fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel for the treatment of acne vulgaris in the Brazilian population.
  
  
  METHODS
  This is a multicenter, open-label and interventionist study. Patients applied 1.0 g of the fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel on the face, once daily at bedtime, during 12 weeks. Lesions were counted in all of the appointments, and the degree of acne severity, overall improvement, tolerability and safety were evaluated in each visit.
  
  
  RESULTS
  From 79 recruited patients, 73 concluded the study. There was significant, fast and progressive reduction of non-inflammatory, inflammatory and total number of lesions. At the end of the study, 75.3% of patients had a reduction of >50% in non-inflammatory lesions, 69.9% in inflammatory lesions and 78.1% in total number of lesions. Of the 73 patients, 71.2% had good to excellent response and 87.6% had satisfactory to good response. In the first week of treatment, erythema, burning, scaling and dryness of the skin were frequent complaints, but, from second week on, these signals and symptoms have reduced.
  
  
  CONCLUSIONS
  The fixed-dose combination of adapalene 0.1% and benzoyl peroxide 2.5% gel is effective, safe, well tolerated and apparently improves patient compliance with the treatment.
authors.affiliation: Hospital do Servidor Público Estadual de São Paulo, São Paulo, SP, Brazil.
authors.forename: José Alexandre de Souza
authors.initials: JA
authors.lastname: Sittart
authors.affiliation: Pontifícia Universidade Católica de Campinas, Campinas, SP, Brazil.
authors.forename: Adilson da
authors.initials: Ad
authors.lastname: Costa
authors.affiliation: Universidade Federal do Paraná, Curitiba, PR, Brazil.
authors.forename: Fabiane
authors.initials: F
authors.lastname: Mulinari-Brenner
authors.affiliation: Universidade Federal da Bahia, Salvador, BA, Brazil.
authors.forename: Ivonise
authors.initials: I
authors.lastname: Follador
authors.affiliation: Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
authors.forename: Luna
authors.initials: L
authors.lastname: Azulay-Abulafia
authors.affiliation: Universidade Federal de Goiás, Goiânia, GO, Brazil.
authors.forename: Lia Cândida Miranda de
authors.initials: LC
authors.lastname: Castro
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy* / Q000473:pathology; D000068801:Adapalene, Benzoyl Peroxide Drug Combination / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001938:Brazil; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000068801:Adapalene, Benzoyl Peroxide Drug Combination; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003879:Dermatologic Agents