To demonstrate the efficacy, therapeutic equivalence and safety of Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A., Inc.) and Ketoconazole 2% Shampoo (Reference Standard) in the treatment of tinea versicolor.
A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Ketoconazole Shampoo, 2% (Taro Pharmaceuticals U.S.A, Inc.) to Ketoconazole Shampoo, 2% (Reference Standard) and both active treatments to a placebo control in the treatment of tinea versicolor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
430
The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
The investigational product was applied on a single occasion topically to the damp skin of the affected area and a wide margin surrounding this area for 5 minutes and then rinsed off with water.
Taro
Hawthorne, New York, United States
To demonstrate the therapeutic equivalence and safety of the Investigational Product
Proportion of subjects with treatment success/cure
Time frame: Day 28 Visit
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