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Topical Antifungal Treatment for Tinea Pedis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396785
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
July 15, 2011
July 19, 2011
August 28, 2013
July 2011
January 2012   (Final data collection date for primary outcome measure)
Proportion of patients achieving complete clearance [ Time Frame: Day 42 ]
Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
Proportion of patients achieving complete clearance [ Time Frame: Day 42 ]
Signs and Symptoms Severity Score and negative KOH and Culture
Complete list of historical versions of study NCT01396785 on ClinicalTrials.gov Archive Site
Proportion of patients achieving effective treatment [ Time Frame: Day 42 ]
Clinical Cure and Mycologic Cure
Same as current
Not Provided
Not Provided
 
Topical Antifungal Treatment for Tinea Pedis
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Pedis
The purpose of this study is to determine if a topical antifungal cream is safe and effective for the treatment of tinea pedis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tinea Pedis
  • Drug: 33525
    Daily for 14 days
  • Drug: Placebo
    Daily for 14 days
  • Experimental: Active
    Product 33525
    Intervention: Drug: 33525
  • Placebo Comparator: Placebo
    Product 33525 Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
March 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate erythema, moderate scaling, and mild pruritus

Exclusion Criteria:

  • Pregnancy and allergies
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT01396785
MP-1000-02
No
Not Provided
Not Provided
Medicis Global Service Corporation
Medicis Global Service Corporation
Not Provided
Study Director: Ron Staugaard Medicis Pharmaceutical
Medicis Global Service Corporation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP