The goal of this clinical study is to find out whether using ketoconazole 2% shampoo for seven days works better than using it for three days in treating pityriasis versicolor. The study will also evaluate the safety of both treatment durations.
The main questions this study aims to answer are:
* Does treatment with ketoconazole 2% shampoo for seven days result in better mycological efficacy compared with three days of treatment in patients with pityriasis versicolor? * Does treatment with ketoconazole 2% shampoo for seven days lead to better clinical improvement compared with three days of treatment? * Are there differences in side effects between the seven-day and three-day ketoconazole 2% shampoo treatment regimens? * Are there differences in dermoscopic features of pityriasis versicolor before and after treatment with ketoconazole 2% shampoo when used for seven days compared with three days?
Male and female patients aged 12 years or older
Patients with pityriasis versicolor confirmed mycologically by the presence of short hyphae and round spores on direct microscopic examination using potassium hydroxide (KOH) preparation and Parker Blue-Black® ink
Patients who are willing to participate in the study and provide written informed consent after receiving adequate explanation of the study; informed assent is obtained for participants younger than 18 years
Participants younger than 18 years who have written permission from a parent or legal guardian
Patients in an immobilized condition
Patients with pityriasis versicolor lesions limited exclusively to the face, without involvement of other body areas
History of hypersensitivity to ketoconazole
Use of systemic antifungal agents or systemic corticosteroids within one month prior to study enrollment
Parallel
Ketoconazole 2% Shampoo
DrugKetoconazole 2% shampoo is a topical antifungal formulation used for the treatment of pityriasis versicolor. It exerts its antifungal effect by inhibiting ergosterol synthesis in Malassezia species.
Placebo Shampoo
DrugPlacebo shampoo is a vehicle formulation identical in appearance, texture, and odor to ketoconazole shampoo but without the active antifungal ingredient. It is used to maintain blinding during the study period.
Proportion of participants with negative KOH microscopy
Mycological cure is defined as a negative result on direct microscopic examination of skin scrapings using potassium hydroxide (KOH) preparation after completion of treatment.
Proportion of participants with resolution of fine scaling
Clinical improvement is assessed based on the resolution of fine scaling associated with pityriasis versicolor on physical examination.
Number of participants with treatment-related local adverse events
Adverse events include any local skin reactions such as pruritus, burning sensation, erythema, or contact dermatitis reported or observed during the treatment period.
Proportion of participants with improvement in dermoscopic scaling
Improvement is defined as the reduction or absence of fine scaling on dermoscopic examination at Day 7 compared with baseline.
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