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

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 Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: Luliconazole Cream 1% - 2 wks; Drug: Luliconazole Cream 1% - 4 wks; Drug: Placebo Comparator -2 wks; Drug: Placebo Comparator - 4 wks

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Fridley, Minnesota, United States, 55432
  • Oregon
    • Portland, Oregon, United States, 97210
  • Texas
    • Austin, Texas, United States, 78759
    • College Station, Texas, United States, 77840

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Luliconazole Cream 1% - 2 wks; Daily treatment with Luliconazole Cream 1% for 2 weeks	Drug: Luliconazole Cream 1% - 2 wks; Topical cream applied daily for 2 weeks
Experimental: Luliconazole Cream 1% - 4 wks; Daily treatment with Luliconazole Cream 1% for 4 weeks	Drug: Luliconazole Cream 1% - 4 wks; Topical cream applied daily for 4 weeks
Placebo Comparator: Placebo Comparator - 2 wks; Daily treatment with Vehicle Cream for 2 weeks	Drug: Placebo Comparator -2 wks; Placebo cream applied daily for 2 weeks
Placebo Comparator: Placebo Comparator - 4 wks; Daily treatment with Vehicle Cream for 4 weeks	Drug: Placebo Comparator - 4 wks; Placebo cream applied daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tinea Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 25, 2009
• First Submitted That Met QC Criteria: March 25, 2009
• First Posted (Estimate): March 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 21, 2011
• Last Update Submitted That Met QC Criteria: June 6, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Tinea Pedis; Athlete's Foot
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Anti-Infective Agents; Antifungal Agents; Luliconazole
• Other Study ID Numbers: TP-0801