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

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07333170
Acronym
P versicolor
Enrollment
86
Registered
2026-01-12
Start date
2026-02-28
Completion date
2026-11-30
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pityriasis Versicolor

Keywords

P versicolor

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.

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.

Interventions

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.

DRUGTopical 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.

Sponsors

PAEC general hospital
CollaboratorOTHER_GOV
PAEC General Hospital, Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* All patients diagnosed with pityriasis versicolor.

Exclusion criteria

* Immunocompromised patients

Design outcomes

Primary

MeasureTime frameDescription
Clinical and mycological cure rate in pityriasis versicolor.4 weeksProportion of participants achieving both clinical and mycological cure.
Clinical and mycological cure4 weeks after completion of treatmentProportion of participants achieving both clinical and mycological cure

Contacts

Primary ContactSana Rafique, MBBS
sanafmdc@gmail.com+923355956563

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026