title: A randomized double-blind, non-inferiority Phase II trial, comparing dapaconazole tosylate 2% cream with ketoconazole 2% cream in the treatment of Pityriasis versicolor.
abstract: OBJECTIVE
  The objective of this research was to evaluate the efficacy of a new antifungal imidazole, dapaconazole tosylate, in the treatment of Pityriasis versicolor (PV).
  
  
  METHODS
  Sixty patients with clinical and mycological diagnosis of PV were randomly assigned to receive either 1 g dapaconazole tosylate 2% cream or 1 g ketoconazole 2% cream. Treatments were applied once a day for 28 days. A dermatologist evaluated efficacy and safety daily, and weekly laboratorial tests were performed. The primary end point was a clinical and mycological cure of lesions after 28 days of treatment. The secondary end point was the time to clinical healing assessed by Kaplan-Meier analysis and Log-rank testing.
  
  
  RESULTS
  Fifty-three patients adhered to protocol rules. Clinical and mycological cure was achieved in 84.6% (22/26) and 92.6% (25/27) of patients treated with ketoconazole and dapaconazole, respectively (difference [effect size] = 8.0%, Standard error of difference: 8.69%, 95% CI: -6.3 to 22.3%). Median time to healing was 23.5 and 21 days for ketoconazole and dapaconazole, respectively (p = 0.126). Adverse events occurred only in ketoconazole-treated patients (13%; 4/30).
  
  
  CONCLUSIONS
  Dapaconazole tosylate is non-inferior to ketoconazole when used at a dose of 20 mg/day for 28 consecutive days for the treatment of PV. Dapaconazole also demonstrated a good safety profile.
authors.affiliation: a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
authors.forename: André Alves Moraes
authors.initials: AA
authors.lastname: Gobbato
authors.affiliation: a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
authors.forename: Tainah
authors.initials: T
authors.lastname: Babadópulos
authors.affiliation: a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
authors.forename: Cintia Aparecida Rodrigues Santiago
authors.initials: CA
authors.lastname: Gobbato
authors.affiliation: b 2 Galeno Research Unit , Campinas, SP, Brazil.
authors.forename: Jaime de Oliveira
authors.initials: Jde O
authors.lastname: Ilha
authors.affiliation: c 3 Federal University of Rio de Janeiro, Institute of Biophysics Carlos Chagas Filho , CCS, Bloco G - 21941-902, Rio de Janeiro RJ, Brazil +55 219 9995 0512 ; +55 193 252 1516 ; thiagogagliano@gmail.com.
authors.forename: Thiago
authors.initials: T
authors.lastname: Gagliano-Jucá
authors.affiliation: a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.|d 4 Mogi das Cruzes University (UMC), Faculty of Medicine , Mogi das Cruzes, SP, Brazil.
authors.forename: Gilberto
authors.initials: G
authors.lastname: De Nucci
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007654:Ketoconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D014010:Tinea Versicolor / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C000593721:1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazole; D000935:Antifungal Agents; D007093:Imidazoles; D007654:Ketoconazole
keywords: Malassezia; Tinea versicolor; imidazole; topical antifungal