Comparison of the Efficacy of Topical Luliconazole 2% Cream vs Topical Ketoconazole 1% Cream in the Treatment of Pityriasis Versicolor. (P versicolor)

January 9, 2026 updated by: Sana Rafique, PAEC General Hospital, Islamabad
Pityriasis versicolor is a common superficial fungal infection caused by Malassezia species, characterized by hypo- or hyper-pigmented scaly patches on the skin. Topical antifungal agents are the mainstay of treatment. Ketoconazole has been widely used; however, newer agents such as luliconazole may offer improved efficacy and shorter treatment duration. This randomized controlled study aims to compare the efficacy and safety of topical luliconazole versus topical ketoconazole in patients with pityriasis versicolor. Treatment response will be assessed clinically and mycologically to determine comparative outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pityriasis versicolor is a superficial fungal infection caused by Malassezia species and is commonly treated with topical antifungal agents. Ketoconazole is a conventional treatment, while luliconazole is a newer topical antifungal with potent activity against fungal organisms. This randomized controlled trial is designed to compare the clinical and mycological efficacy, safety, and tolerability of topical luliconazole versus topical ketoconazole in patients diagnosed with pityriasis versicolor. Eligible participants will be randomly allocated into two treatment groups and followed for treatment response and adverse effects. The findings of this study may help determine a more effective topical treatment option for pityriasis versicolor.

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients diagnosed with pityriasis versicolor.

Exclusion Criteria:

  • Immunocompromised patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topical Luliconazole 1% cream
Participants will receive topical luliconazole 1% cream applied once daily to affected areas for the treatment of pityriasis versicolor.
Drug: Luliconazole Cream 1%
Ketoconazole is relatively hydrophilic with limited skin retention, whereas luliconazole is highly lipophilic, resulting in superior stratum corneum penetration, higher keratin binding, and prolonged antifungal activity.
Experimental: Topical ketoconazole 2% cream
Participants will receive topical ketoconazole 2% cream applied twice daily to affected areas for the treatment of pityriasis versicolor.
Drug: Topical ketoconazole 2% cream
Ketoconazole is relatively hydrophilic with limited skin retention, whereas luliconazole is highly lipophilic, resulting in superior stratum corneum penetration, higher keratin binding, and prolonged antifungal activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and mycological cure rate in pityriasis versicolor.
Time Frame: 4 weeks
Proportion of participants achieving both clinical and mycological cure.
4 weeks
Clinical and mycological cure
Time Frame: 4 weeks after completion of treatment
Proportion of participants achieving both clinical and mycological cure
4 weeks after completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PAEC General Hospital, Islamabad

Collaborators

PAEC general hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

January 9, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAECIslamabad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data from this study will not be shared, as it is a small, single center based study. aggregate forms will be used to analyze the results. To ensure patients confidentiality data sharing is limited. Beyond the stated study object the dataset will not be used for any secondary purpose.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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