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

NCT07333170 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: PAECIslamabad
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pityriasis Versicolor

Keywords

P versicolor

Outcome Measures

Primary Outcomes (2)

• Clinical and mycological cure rate in pityriasis versicolor.

  Proportion of participants achieving both clinical and mycological cure.

  4 weeks

• Clinical and mycological cure

  Proportion of participants achieving both clinical and mycological cure

  4 weeks after completion of treatment

Study Arms (2)

Topical Luliconazole 1% cream

EXPERIMENTAL

Participants will receive topical luliconazole 1% cream applied once daily to affected areas for the treatment of pityriasis versicolor.

Drug: Luliconazole Cream 1%

Topical ketoconazole 2% cream

EXPERIMENTAL

Participants will receive topical ketoconazole 2% cream applied twice daily to affected areas for the treatment of pityriasis versicolor.

Drug: Topical ketoconazole 2% cream

Interventions

Topical ketoconazole 2% cream DRUG

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.

Topical ketoconazole 2% cream

Luliconazole Cream 1% DRUG

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.

Topical Luliconazole 1% cream

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All patients diagnosed with pityriasis versicolor.

You may not qualify if:

• Immunocompromised patients

Sponsors & Collaborators

• PAEC General Hospital, Islamabad: lead
• PAEC general hospital: collaborator

Related Links

• Related Info

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

Central Study Contacts

Sana Rafique, MBBS

CONTACT

+923355956563; sanafmdc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study; no participants, care providers, investigators, or outcome assessors are masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate trainee

Model Details: Participants will be randomly assigned into two parallel groups. One group will receive topical luliconazole, while the other group will receive topical ketoconazole for the treatment of pityriasis versicolor. Clinical and mycological outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share