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A randomized double-blind, non-inferiority Phase II trial, comparing dapaconazole tosylate 2% cream with ketoconazole 2% cream in the treatment of Pityriasis versicolor.
Gobbato, André Alves Moraes; Babadópulos, Tainah; Gobbato, Cintia Aparecida Rodrigues Santiago; Ilha, Jaime de Oliveira; Gagliano-Jucá, Thiago; De Nucci, Gilberto.
Afiliação
  • Gobbato AA; a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
  • Babadópulos T; a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
  • Gobbato CA; a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
  • Ilha Jde O; b 2 Galeno Research Unit , Campinas, SP, Brazil.
  • Gagliano-Jucá T; 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.
  • De Nucci G; a 1 State University of Campinas (UNICAMP), Faculty of Medical Sciences, Department of Pharmacology , Campinas, SP, Brazil.
Expert Opin Investig Drugs ; 24(11): 1399-407, 2015.
Article em En | MEDLINE | ID: mdl-26419668
OBJECTIVES: The objective of this research was to evaluate the efficacy of a new antifungal imidazole, dapaconazole tosylate, in the treatment of Pityriasis versicolor (PV). DESIGN AND 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). CONCLUSION: 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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tinha Versicolor / Imidazóis / Cetoconazol Tipo de estudo: Clinical_trials / Guideline Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Expert Opin Investig Drugs Assunto da revista: TERAPIA POR MEDICAMENTOS Ano de publicação: 2015 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido
Texto completo
Adicionar na Minha BVS
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Tinha Versicolor / Imidazóis / Cetoconazol Tipo de estudo: Clinical_trials / Guideline Limite: Adolescent / Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Expert Opin Investig Drugs Assunto da revista: TERAPIA POR MEDICAMENTOS Ano de publicação: 2015 Tipo de documento: Article País de afiliação: Brasil País de publicação: Reino Unido