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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorFakultas Kedokteran Universitas Indonesia

About this trial

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?

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ketoconazole 2% Shampoo
  • Placebo Shampoo

Treatment groups

76 Participants
are divided into 2 treatment groups

Locations

This trial has no locations