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

NCT07471178 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 25-08-1311
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief 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?

Conditions

Pityriasis Versicolor

Keywords

Pityriasis Versicolor; Ketoconazole; Mycological Cure

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 7 after initiation of treatment

Secondary Outcomes (3)

• Proportion of participants with resolution of fine scaling

  Day 7 after initiation of treatment

• Number of participants with treatment-related local adverse events

  During the 7-day treatment period

• Proportion of participants with improvement in dermoscopic scaling

  During the 7-day treatment period

Study Arms (2)

Ketoconazole 2% Shampoo - 7-Day Regimen

EXPERIMENTAL

Participants receive ketoconazole 2% shampoo, applied once daily to affected skin areas or the whole body, as instructed. The shampoo is left on the skin for 5 minutes before rinsing. Treatment is administered for seven consecutive days.

Drug: Ketoconazole 2% Shampoo

Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo

ACTIVE COMPARATOR

Participants receive ketoconazole 2% shampoo, applied once daily for three consecutive days, followed by a placebo shampoo once daily for four additional days, resulting in a total treatment duration of seven days. The shampoo is left on the skin for 5 minutes before rinsing. The application method is identical in both arms.

Drug: Ketoconazole 2% Shampoo; Drug: Placebo Shampoo

Interventions

Ketoconazole 2% Shampoo DRUG

Ketoconazole 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.

Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo; Ketoconazole 2% Shampoo - 7-Day Regimen

Placebo Shampoo DRUG

Placebo 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.

Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

MeSH Terms

Conditions

Tinea Versicolor

Interventions

Ketoconazole

Condition Hierarchy (Ancestors)

Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Eliza Miranda, MD, PhD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luddwi A Rizky, MD

CONTACT

+6281196111110; luddwiar@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors are blinded to treatment allocation. Both study groups receive identically packaged shampoos. In the three-day group, ketoconazole 2% shampoo is administered for three days followed by a placebo shampoo for four days, while the seven-day group receives ketoconazole 2% shampoo for seven days. Blinding is maintained throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Model Details: This study uses a parallel interventional study model. Eligible participants with pityriasis versicolor are randomly assigned to one of two treatment groups and followed concurrently throughout the study period. One group receives ketoconazole 2% shampoo once daily for seven consecutive days. The comparison group receives ketoconazole 2% shampoo once daily for three consecutive days, followed by a placebo shampoo for the remaining four days, resulting in a total treatment period of seven days in both groups. Each participant is assigned to a single treatment group and does not switch interventions during the study. Randomization is performed using a concealed allocation sequence, and both participants and investigators are blinded to group assignment. The parallel design allows direct comparison of treatment duration effects on efficacy and safety while maintaining identical treatment duration and blinding between groups.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: March 13, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share