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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00869336

Enrollment

147

Registered

2009-03-26

Start date

2009-03-31

Completion date

2009-09-30

Last updated

2011-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinea Pedis

Keywords

Tinea Pedis, Athlete's Foot

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.

Interventions

DRUGLuliconazole Cream 1% - 2 wks

Topical cream applied daily for 2 weeks

DRUGPlacebo Comparator -2 wks

Placebo cream applied daily for 2 weeks

DRUGLuliconazole Cream 1% - 4 wks

Topical cream applied daily for 4 weeks

DRUGPlacebo Comparator - 4 wks

Placebo cream applied daily for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Proportion of subjects who achieve complete clearance at 2 weeks post treatment	Two weeks post treatment

Secondary

Measure	Time frame
Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment	2 and 4 weeks post treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026