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

Tinea Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Tinea Pedis

Treatments: Drug: Luliconazole Cream 1% - 4 wks; Drug: Placebo Comparator - 4 wks; Drug: Luliconazole Cream 1% - 2 wks; Drug: Placebo Comparator -2 wks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869336

TP-0801

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 4 patient groups, including a placebo group

Luliconazole Cream 1% - 2 wks

Experimental group

Description:

Daily treatment with Luliconazole Cream 1% for 2 weeks

Treatment:

Drug: Luliconazole Cream 1% - 2 wks

Luliconazole Cream 1% - 4 wks

Experimental group

Description:

Daily treatment with Luliconazole Cream 1% for 4 weeks

Treatment:

Drug: Luliconazole Cream 1% - 4 wks

Placebo Comparator - 2 wks

Placebo Comparator group

Description:

Daily treatment with Vehicle Cream for 2 weeks

Treatment:

Drug: Placebo Comparator -2 wks

Placebo Comparator - 4 wks

Placebo Comparator group

Description:

Daily treatment with Vehicle Cream for 4 weeks

Treatment:

Drug: Placebo Comparator - 4 wks