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Topical Antifungal Treatment for Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tinea Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01396811
First received: July 15, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.


Condition Intervention Phase
Tinea Pedis
 Drug: 33525
Drug: Placebo
 Phase 3

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: A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tinea Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients achieving complete clearance [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Signs and Symptoms Severity Score and negative KOH and Culture


Secondary Outcome Measures:
  • Proportion of patients achieving effective treatment [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    Clinical Cure and Mycologic Cure


Enrollment: 322
Study Start Date: July 2011
Study Completion Date: March 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Product 33525
 Drug: 33525
Daily for 14 days
Placebo Comparator: Placebo
Product 33525 Placebo
 Drug: Placebo
Daily for 14 days

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

  • Pregnancy and allergies
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396811

Locations
United States, Florida
Miami, Florida, United States
Miramar, Florida, United States
United States, Georgia
Augusta, Georgia, United States
United States, Indiana
Evansville, Indiana, United States
United States, Michigan
Warren, Michigan, United States
United States, New Jersey
Hackensack, New Jersey, United States
United States, North Carolina
High Point, North Carolina, United States
United States, Ohio
Cinncinnati, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Tennessee
Nashville, Tennessee, United States
Belize
Belize City, Belize
Sponsors and Collaborators
Tinea Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tinea Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01396811     History of Changes
Other Study ID Numbers: MP-1000-03
Study First Received: July 15, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tinea Pharmaceuticals:
Tinea Pedis
Antifungal

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
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013