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

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.

• Authors: André Alves Moraes Gobbato, Tainah Babadópulos, Cintia Aparecida Rodrigues Santiago Gobbato, Jaime de Oliveira Ilha, Thiago Gagliano-Jucá, Gilberto De Nucci
• Journal: Expert opinion on investigational drugs (Expert Opin Investig Drugs) Vol. 24 Issue 11 Pg. 1399-407 ( 2015) ISSN: 1744-7658 [Electronic] England
• PMID: 26419668 (Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• 1-(2-(2,4-dichlorophenyl)-2-(4-(trifluoromethyl)benzyloxy)ethyl)-1H-imidazole
• Antifungal Agents
• Imidazoles
• Ketoconazole

Topics

• Administration, Cutaneous
• Adolescent
• Adult
• Antifungal Agents (administration & dosage, adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Humans
• Imidazoles (administration & dosage, adverse effects, therapeutic use)
• Ketoconazole (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Tinea Versicolor (drug therapy, pathology)
• Treatment Outcome
• Young Adult