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: NCT01396785
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 : 321 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
Primary Completion Date : January 2012
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): NCT01396785

United States, California
Los Angeles, California, United States
United States, New Jersey
Paramus, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
College Station, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Puerto Rico
Cidra, Puerto Rico
Sponsors and Collaborators
Medicis Global Service Corporation
Study Director: Ron Staugaard Medicis Pharmaceutical

Responsible Party: Medicis Global Service Corporation Identifier: NCT01396785     History of Changes
Other Study ID Numbers: MP-1000-02
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