The study is designed to compare the efficacy of topical tacrolimus and topical clotrimazole in the treatment of tinea versicolor.
The study is a randomized, triple-blind, controlled with standard treatment, unicenter, phase II clinical trial.
Inclusion criteria include clinical diagnosis of tinea versicolor, confirmation of diagnosis by Wood's lamp examination (Yellow fluorescence) and Direct smear, patients of 10 year old and over, and less than 15% of body surface area involvement.
Exclusion criteria include pregnancy or lactation, history of hypersensitivity to main or preservative ingredients of topical tacrolimus or clotrimazole, serious skin or systemic diseases, and history of consumption of topical or systemic antifungal medications in the recent 1 month before enrolling in the study.
The patients were selected by convenient sampling from tinea versicolor patients referred to dermatology clinic of Faghihi hospital in Shiraz and 50 patients were enrolled in the study. The patients were divided into two groups with 25 patients in each by block randomization.
Intervention group applied tacrolimus 0.03% ointment on tinea versicolor skin lesions two times a day for 21 days and control group applied clotrimazole 1% cream on tinea versicolor skin lesions two times a day for 21 days.
Primary outcome measures were Wood's lamp fluorescence, scale and hyperpigmentation grade, and Malassezia species positivity which were assessed in the 0, 3rd, and 5th week of the study.