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

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2009-09-30

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.

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Detailed Description

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Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Luliconazole Cream 1% - 2 wks

Daily treatment with Luliconazole Cream 1% for 2 weeks

Group Type EXPERIMENTAL

Luliconazole Cream 1% - 2 wks

Intervention Type DRUG

Topical cream applied daily for 2 weeks

Luliconazole Cream 1% - 4 wks

Daily treatment with Luliconazole Cream 1% for 4 weeks

Group Type EXPERIMENTAL

Luliconazole Cream 1% - 4 wks

Intervention Type DRUG

Topical cream applied daily for 4 weeks

Placebo Comparator - 2 wks

Daily treatment with Vehicle Cream for 2 weeks

Group Type PLACEBO_COMPARATOR

Placebo Comparator -2 wks

Intervention Type DRUG

Placebo cream applied daily for 2 weeks

Placebo Comparator - 4 wks

Daily treatment with Vehicle Cream for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo Comparator - 4 wks

Intervention Type DRUG

Placebo cream applied daily for 4 weeks

Interventions

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Luliconazole Cream 1% - 2 wks

Topical cream applied daily for 2 weeks

Intervention Type DRUG

Placebo Comparator -2 wks

Placebo cream applied daily for 2 weeks

Intervention Type DRUG

Luliconazole Cream 1% - 4 wks

Topical cream applied daily for 4 weeks

Intervention Type DRUG

Placebo Comparator - 4 wks

Placebo cream applied daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Subjects of either gender must be 12 years of age or older.
2. 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.
3. Subjects with a mycological diagnosis of interdigital tinea pedis confirmed by the detection of fungal hyphae on a microscopic KOH wet mount
4. Females of child-bearing potential must have a negative urine pregnancy test and must agree to use an effective form of contraception

Exclusion Criteria

1. 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;
2. Female subjects who are pregnant and/or nursing or planning a pregnancy during the course of the trial.
3. Subjects who are immunocompromised (due to disease, e.g., HIV or medications
4. Subjects with a history of intolerance or hypersensitivity to imidazole compounds or the inactive components of the cream;
5. Subjects with a life-threatening condition (e.g., autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
6. Subjects using the following medications:

1. topical antifungal agent within 30 days of the baseline visit
2. systemic antifungals within 8 weeks of the baseline visit (8 months for oral terbinafine)
3. topical corticosteroid in treatment area(s) within 30 days of the baseline visit.
4. systemic corticosteroids within 30 days of the baseline visit;
5. any other topical medicated topical treatments to the treatment area(s) within 7 days of baseline visit.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No