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
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:

Further study details as provided by Medicis Global Service Corporation:

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 Potassium Hydroxide (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


Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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: 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
  More Information

Responsible Party: Medicis Global Service Corporation Identifier: NCT01396811     History of Changes
Other Study ID Numbers: MP-1000-03 
Study First Received: July 15, 2011
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Medicis Global Service Corporation:
Tinea Pedis

Additional relevant MeSH terms:
Tinea Pedis
Foot Dermatoses
Foot Diseases
Signs and Symptoms
Skin Diseases
Skin Diseases, Infectious
Skin Manifestations processed this record on May 26, 2016