Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)

This study has been completed.
Sponsor:
Information provided by:
Tinea Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00869336
First received: March 25, 2009
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Tinea Pedis
Drug: Luliconazole Cream 1% - 2 wks
Drug: Placebo Comparator -2 wks
Drug: Luliconazole Cream 1% - 4 wks
Drug: Placebo Comparator - 4 wks
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Tinea Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of subjects who achieve complete clearance at 2 weeks post treatment [ Time Frame: Two weeks post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve effective treatment at 2 and 4 weeks post treatment [ Time Frame: 2 and 4 weeks post treatment ] [ Designated as safety issue: Yes ]

Enrollment: 147
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869336

Locations
United States, Minnesota
Fridley, Minnesota, United States, 55432
United States, Oregon
Portland, Oregon, United States, 97210
United States, Texas
Austin, Texas, United States, 78759
College Station, Texas, United States, 77840
Sponsors and Collaborators
Tinea Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tinea Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00869336     History of Changes
Other Study ID Numbers: TP-0801
Study First Received: March 25, 2009
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Tinea Pharmaceuticals:
Tinea Pedis
Athlete's Foot

Additional relevant MeSH terms:
Tinea
Tinea Pedis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Foot Dermatoses
Foot Diseases
Pruritus
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014