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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pityriasis Versicolor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open-label study; no participants, care providers, investigators, or outcome assessors are masked.

Study Groups

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Topical Luliconazole 1% cream

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

Group Type EXPERIMENTAL

Luliconazole Cream 1%

Intervention Type 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

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

Group Type EXPERIMENTAL

Topical ketoconazole 2% cream

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG