Topical Antifungal Treatment for Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01396785
First received: July 15, 2011
Last updated: August 20, 2013
Last verified: August 2013
  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:


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: 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

  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
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 ClinicalTrials.gov identifier: NCT01396785

Locations
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
Investigators
Study Director: Ron Staugaard Medicis Pharmaceutical
  More Information

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01396785     History of Changes
Other Study ID Numbers: MP-1000-02
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
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 July 24, 2014