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Topical Antifungal Treatment for Tinea Pedis

This study has been completed.
Information provided by (Responsible Party):
Medicis Global Service Corporation Identifier:
First received: July 15, 2011
Last updated: August 20, 2013
Last verified: August 2013
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
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by Medicis Global Service Corporation:

Primary Outcome Measures:
  • 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:
  • Proportion of patients achieving effective treatment [ Time Frame: Day 42 ]
    Clinical Cure and Mycologic Cure

Enrollment: 321
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


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
  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 identifier: 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
  More Information

Responsible Party: Medicis Global Service Corporation Identifier: NCT01396785     History of Changes
Other Study ID Numbers: MP-1000-02
Study First Received: July 15, 2011
Last Updated: August 20, 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 processed this record on April 21, 2017