Not Yet RecruitingPhase 4

Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor

76 participantsStarted 2026-02

Plain-language summary

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?

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Use of topical antifungal agents or topical corticosteroids within two weeks prior to study enrollment * Patients with severe immunosuppression * Pregnant or breastfeeding women

What they're measuring

Proportion of participants with negative KOH microscopy

Timeframe: Day 7 after initiation of treatment

Trial details

NCT IDNCT07471178

SponsorFakultas Kedokteran Universitas Indonesia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Luddwi A Rizky, MD

+6281196111110 luddwiar@gmail.com