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Topical Antifungal Treatment for Tinea Pedis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396811
First Posted: July 19, 2011
Last Update Posted: August 28, 2013
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.
Information provided by (Responsible Party):
Medicis Global Service Corporation
  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
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

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: 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

  • Pregnancy and allergies
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01396811


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

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01396811     History of Changes
Other Study ID Numbers: MP-1000-03
First Submitted: July 15, 2011
First Posted: July 19, 2011
Last Update Posted: August 28, 2013
Last Verified: August 2013

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