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

Phase 2

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Luliconazole Cream 1% - 4 wks; Drug: Luliconazole Cream 1% - 2 wks; Drug: Placebo Comparator -2 wks; Drug: Placebo Comparator - 4 wks

• Registration Number: NCT00869336
• Lead Sponsor: Tinea Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-25
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-06
• Disposition First Submitted: 2011-06-06
• Disposition First Submitted QC: 2011-06-06
• Last Update Submitted: 2011-06-06
• Disposition First Posted: 2011-06-21
• Last Update Posted: 2011-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Luliconazole Cream 1% - 4 wks	Luliconazole Cream 1% - 4 wks	Daily treatment with Luliconazole Cream 1% for 4 weeks
Luliconazole Cream 1% - 2 wks	Luliconazole Cream 1% - 2 wks	Daily treatment with Luliconazole Cream 1% for 2 weeks
Placebo Comparator - 2 wks	Placebo Comparator -2 wks	Daily treatment with Vehicle Cream for 2 weeks
Placebo Comparator - 4 wks	Placebo Comparator - 4 wks	Daily treatment with Vehicle Cream for 4 weeks

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve complete clearance at 2 weeks post treatment	Two weeks post treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment	2 and 4 weeks post treatment