Trial | NCT00869336  Report issue

Title

Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
Phase 2 Study - A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Duration Finding Study Evaluating the Efficacy and Safety of Two Week and Four Week Once Daily Treatment of Luliconazole Cream 1% in Patients With Tinea Pedis

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    luliconazole ...

  • Study Participants

    147
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.
Study Started
Mar 31
2009
Primary Completion
Sep 30
2009
Study Completion
Sep 30
2009
Last Update
Jun 21
2011
Estimate

Drug Luliconazole Cream 1% - 2 wks

Topical cream applied daily for 2 weeks

Drug Placebo Comparator -2 wks

Placebo cream applied daily for 2 weeks

Drug Luliconazole Cream 1% - 4 wks

Topical cream applied daily for 4 weeks

Drug Placebo Comparator - 4 wks

Placebo cream applied daily for 4 weeks

Luliconazole Cream 1% - 2 wks Experimental

Daily treatment with Luliconazole Cream 1% for 2 weeks

Luliconazole Cream 1% - 4 wks Experimental

Daily treatment with Luliconazole Cream 1% for 4 weeks

Placebo Comparator - 2 wks Placebo Comparator

Daily treatment with Vehicle Cream for 2 weeks

Placebo Comparator - 4 wks Placebo Comparator

Daily treatment with Vehicle Cream for 4 weeks

Criteria 

Inclusion Criteria:

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 Criteria:

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.
No Results Posted