Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)

Study Overview
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Brief Summary
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To examine the safety and optimal duration of Luliconazole Cream 1% treatments for 14 days or 28 days to achieve complete clearance at 2 weeks post treatment.

Official Title
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Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis

Conditions
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Tinea Pedis

Intervention / Treatment
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* Drug: Luliconazole Cream 1% - 2 wks
* Drug: Placebo Comparator -2 wks
* Drug: Luliconazole Cream 1% - 4 wks
* Drug: Placebo Comparator - 4 wks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either gender must be 12 years of age or older. Subjects with a clinical diagnosis of interdigital tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling, and mild pruritus) based on signs and symptoms. Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception Exclusion Criteria: Subjects with moccasin (dry type) tinea pedis; with concomitant onychomycosis of the fingernails and/or toenails on the evaluated foot, with severe dermatophytoses, a concurrent tinea infection or bacterial skin infection on the evaluated foot; Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial. Subjects who are immunocompromised (due to disease, e.g., HIV or medications Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream; Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months. Subjects using the following medications: topical antifungal agent within 30 days of the baseline visit systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine) topical corticosteroid in treatment area(s) within 30 days of the baseline visit. systemic corticosteroids within 30 days of the baseline visit; any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luliconazole Cream 1% - 2 wks<br>Daily treatment with Luliconazole Cream 1% for 2 weeks | Drug: Luliconazole Cream 1% - 2 wks<br>* Topical cream applied daily for 2 weeks<br>|
| Experimental: Luliconazole Cream 1% - 4 wks<br>Daily treatment with Luliconazole Cream 1% for 4 weeks | Drug: Luliconazole Cream 1% - 4 wks<br>* Topical cream applied daily for 4 weeks<br>|
| Placebo Comparator: Placebo Comparator - 2 wks<br>Daily treatment with Vehicle Cream for 2 weeks | Drug: Placebo Comparator -2 wks<br>* Placebo cream applied daily for 2 weeks<br>|
| Placebo Comparator: Placebo Comparator - 4 wks<br>Daily treatment with Vehicle Cream for 4 weeks | Drug: Placebo Comparator - 4 wks<br>* Placebo cream applied daily for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve complete clearance at 2 weeks post treatment |  | Two weeks post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment |  | 2 and 4 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tinea Pedis, Athlete's Foot