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

Completed · Phase 2 · Has a placebo group

Conditions studied: Tinea Pedis

In brief

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.

Key facts

Study ID

NCT00869336

Run by

Tinea Pharmaceuticals

People needed

147

Starts

2009-03-01

Expected to finish

2009-09-01

Last updated by the study team

2011-06-21

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Fridley, Minnesota, United States
• Study site — Portland, Oregon, United States
• Study site — Austin, Texas, United States
• Study site — College Station, Texas, United States

Full record on ClinicalTrials.gov

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