Tinea versicolor treated with terbinafine 1% solution


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Abstract

A double-blind, prospective, parallel-group study was conducted to evaluate the efficacy of 1% terbinafine solution for the treatment of pityriasis (tinea) versicolor. One hundred and fifty-two patients from 10 centers in the USA were enrolled. Eligible patients were males or nonpregnant females of at least 12 years of age with clinical diagnoses of tinea versicolor confirmed by positive microscopy and total signs and symptoms scores of at least 2 (measured by severity of erythema, desquamation, and pruritus, each on a scale of 0 = absent to 3 = severe).Patients were randomized, at a 2 : 1 ratio, to receive either 1% terbinafine-in a vehicle solution containing propylene glycol-1,2, cetomacrogol 1000, ethanol, and demineralized water-or vehicle solution alone in identical 20-mL bottles. They were instructed to apply the solution (via dropper bottle) to all fungal lesions, spreading the solution to cover the entire affected area and 1 inch beyond.Treatment consisted of twice-daily application of study drug or vehicle for seven consecutive days. Clinical efficacy was assessed at the end of the week-long treatment period (week 1) and during follow-up at weeks 2, 4, and 8. Samples of the target lesions were taken for microscopic examination at baseline and at weeks 1, 2, 4, and 8.The target lesions were clinically assessed by scoring the severity of erythema, desquamation, and pruritus from 0 to 3. Treatment was scored as effective (complete cure) if microscopy was negative (no budding yeast or hyphae) and the total signs and symptoms score (sum of individual scores for erythema, desquamation, and pruritus) was 1 or less. At week 8, investigators and patients also assessed the overall efficacy of treatment using a scale of 1 (very good) to 5 (very poor).

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