Comparative clinical trial: fluconazole alone or associated with topical ketoconazole in the treatment of pityriasis versicolor.

BACKGROUND: The efficacy of ketoconazole and fluconazole in pityriasis versicolor had been proved. AIM: To compare the efficacy and the safety of two doses of fluconazole given 1 week apart alone or associated to ketoconazole shampoo. METHODS: Our study included all patients with pityriasis versicolor who attended in dermatology department of Habib Thameur Hospital, Tunis (over a 21-month period). During the considered period, patients were randomly assigned in two study groups: G1 receiving fluconazole two doses 300mg given 1 week apart with G2 taken an association of fluconazole (two doses 300mg given 1 week apart) and ketoconazole shampoo the first day. RESULTS: Seventy one patients were enrolled in our study: 35 in the fluconazole group and 36 in the fluconazole associated to ketoconazole shampoo comparator group. The mean age was 29.1 years [16-70 years]. Concerning the clinical form, 27% had macular lesions, 24% had plaques and 49% had mixed form. Lesions werehyperchromic52%; hypochromic 15% and erythematous 6%. As for main location, 67% had lesions on the neck; 66% on the trunk, 60% on the shoulders. At the end of the study, there was no significant difference in clinical presentation and in improvement rate of pityriasis versicolor between fluconazole and association of fluconazole and ketoconazole shampoo ((p=0.13 at day 14, p=0.57 at day 28 and p=0.2 at day56). CONCLUSION: In this study, we have shown that the improvement rate of PV treated with two doses of 300 mg of fluconazole with one week interval was similar to those of an association of one application of ketoconazole shampoo and the same dose of fluconazole.