Status:
COMPLETED
Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
Lead Sponsor:
Tinea Pharmaceuticals
Conditions:
Tinea Pedis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00869336
Start Date
March 1 2009
End Date
September 1 2009
Last Update
June 21 2011
Active Locations (4)
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1
Fridley, Minnesota, United States, 55432
2
Portland, Oregon, United States, 97210
3
Austin, Texas, United States, 78759
4
College Station, Texas, United States, 77840