Clinical trial NCT00869336: Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Keywords: Tinea Pedis
Athlete's Foot
Lead sponsor: Tinea Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-26
Enrollment: 147
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Proportion of subjects who achieve complete clearance at 2 weeks post treatment
timeFrame: Two weeks post treatment
Secondary outcomes:
measure: Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment
timeFrame: 2 and 4 weeks post treatment
Other outcomes:
Locations:
city: Fridley
country: United States
state: Minnesota
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
Study officials:
References: