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

Mycological Efficacy and Safety of Ketoconazole 2% Shampoo With a Seven-Day Versus Three-Day Treatment Duration in Pityriasis Versicolor: A Double-Blind Randomized Clinical 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?

Study Overview

• Status: Not yet recruiting
• Conditions: Pityriasis Versicolor
• Intervention / Treatment: Drug: Ketoconazole 2% Shampoo; Drug: Placebo Shampoo

Detailed Description

This study is a double-blind randomized clinical trial designed to compare the effectiveness and safety of two different treatment durations of ketoconazole 2% shampoo in patients with pityriasis versicolor, a common superficial fungal infection caused by Malassezia species, particularly prevalent in tropical climates.

The study is conducted in outpatient dermatology clinics in Indonesia, where high temperature and humidity may contribute to persistent or suboptimal treatment responses with standard short-course topical therapy. Current clinical practice commonly recommends a three-day regimen of ketoconazole 2% shampoo; however, longer exposure may be necessary to achieve adequate antifungal activity under tropical conditions. This trial evaluates whether extending treatment to seven days provides superior therapeutic benefit while maintaining an acceptable safety profile.

Eligible participants with a confirmed diagnosis of pityriasis versicolor are randomly assigned to receive ketoconazole 2% shampoo for either three consecutive days or seven consecutive days. Randomization is performed using a concealed allocation sequence. Both participants and investigators are blinded to treatment allocation. The shampoo formulation, packaging, and labeling are identical in both groups to maintain blinding throughout the study.

Participants are instructed to apply the shampoo to affected areas or the entire body, as indicated, once daily according to the assigned regimen. The shampoo is left on the skin for a standardized duration before rinsing. No additional antifungal treatments are permitted during the study period.

Clinical and mycological evaluations are performed at baseline and during follow-up visits. Mycological assessment is conducted using direct microscopic examination of skin scrapings. Clinical evaluation includes physical examination of skin lesions and documentation of treatment response. Dermoscopic examination is performed as supportive data to assess morphological changes before and after therapy.

Safety monitoring is conducted throughout the study. Participants are instructed to report any adverse skin reactions, including irritation, burning sensation, pruritus, or signs suggestive of contact dermatitis. All adverse events are recorded and managed according to predefined safety procedures.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Luddwi A Rizky, MD; Phone Number: +6281196111110; Email: luddwiar@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketoconazole 2% Shampoo - 7-Day Regimen; 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 is a topical antifungal formulation used for the treatment of pityriasis versicolor. It exerts its antifungal effect by inhibiting ergosterol synthesis in Malassezia species.
Active Comparator: Ketoconazole 2% Shampoo - 3-Day Regimen with Placebo; 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; 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.; Drug: Placebo Shampoo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 7 after initiation of treatment
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.	During the 7-day 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.	During the 7-day treatment period

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Eliza Miranda, MD, PhD, Fakultas Kedokteran Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ketoconazole; Pityriasis Versicolor; Mycological Cure
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Dermatomycoses; Skin and Connective Tissue Diseases; Tinea Versicolor; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Ketoconazole
• Other Study ID Numbers: 25-08-1311

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other researchers. All data collected in this study will be used solely for the purposes of the study protocol and related publications, and will be reported only in aggregate form to protect participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No