Topical Antifungal Treatment for Tinea Pedis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01396811
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Medicis Global Service Corporation

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

Condition or disease Intervention/treatment Phase
Tinea Pedis Drug: 33525 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active
Product 33525
Drug: 33525
Daily for 14 days
Placebo Comparator: Placebo
Product 33525 Placebo
Drug: Placebo
Daily for 14 days

Primary Outcome Measures :
  1. Proportion of patients achieving complete clearance [ Time Frame: Day 42 ]
    Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures :
  1. Proportion of patients achieving effective treatment [ Time Frame: Day 42 ]
    Clinical Cure and Mycologic Cure

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

  • Pregnancy and allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01396811

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 City, Belize
Sponsors and Collaborators
Medicis Global Service Corporation
Study Director: Ron Staugaard Medicis Pharmaceutical

Responsible Party: Medicis Global Service Corporation Identifier: NCT01396811     History of Changes
Other Study ID Numbers: MP-1000-03
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Medicis Global Service Corporation:
Tinea Pedis

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