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Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot)
This study is currently recruiting participants.
Verified by Topica Pharmaceuticals, Inc., April 2009
First Received: March 25, 2009   Last Updated: April 21, 2009   History of Changes
Sponsored by: Topica Pharmaceuticals, Inc.
Information provided by: Topica Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00869336
  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 II

MedlinePlus related topics: Athlete's Foot Foot Health Tinea Infections
Drug Information available for: Luliconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Topica Pharmaceuticals, Inc.:

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 ]

Estimated Enrollment: 150
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Luliconazole Cream 1% - 2 wks: Experimental Drug: Luliconazole Cream 1% - 2 wks
Topical cream applied daily for 2 weeks
Luliconazole Cream 1% - 4 wks: Experimental Drug: Luliconazole Cream 1% - 4 wks
Topical cream applied daily for 4 weeks
Placebo Comparator - 2 wks: Placebo Comparator Drug: Placebo Comparator -2 wks
Placebo cream applied daily for 2 weeks
Placebo Comparator - 4 wks: Placebo Comparator 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869336

Contacts
Contact: Kathleen O. Ashenfelter, MS 973 331 1620 kashenfelter@cu-tech.com

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

No publications provided

Responsible Party: Topica Pharmaceuticals, Inc. ( Topical Pharmaceuticals, Inc. )
Study ID Numbers: TP-0801
Study First Received: March 25, 2009
Last Updated: April 21, 2009
ClinicalTrials.gov Identifier: NCT00869336     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Topica Pharmaceuticals, Inc.:
Tinea Pedis
Athlete's Foot

Study placed in the following topic categories:
Pruritus
Mycoses
Signs and Symptoms
Tinea Pedis
Skin Diseases, Infectious
Skin Diseases
Foot Diseases
Tinea
Dermatomycoses

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

ClinicalTrials.gov processed this record on May 07, 2009