- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342315
Topical Antifungal Treatment for Tinea Cruris
August 20, 2013 updated by: Medicis Global Service Corporation
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris
Study Overview
Study Type
Interventional
Enrollment (Actual)
483
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belize City, Belize
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San Salvador, El Salvador
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San Pedro Sula, Honduras
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Cidra, Puerto Rico
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California
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Fremont, California, United States
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Los Angeles, California, United States
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Florida
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Miami, Florida, United States
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Miramar, Florida, United States
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St. Petersburg, Florida, United States
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Indiana
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Evansville, Indiana, United States
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Michigan
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Warren, Michigan, United States
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New Jersey
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Paramus, New Jersey, United States
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New Mexico
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Albuquerque, New Mexico, United States
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Ohio
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Cincinatti, Ohio, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Tennessee
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Goodletsville, Tennessee, United States
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Texas
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Austin, Texas, United States
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College Station, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Virginia
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Lynchburg, Virginia, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- moderate erythema, mild scaling, and moderate pruritis
Exclusion Criteria:
- pregnancy and allergies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active
Product 33525
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Daily dosing
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Experimental: Placebo
Product 33525 Placebo
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Daily dosing
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients achieving complete clearance
Time Frame: 3 weeks post-treatment
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Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture
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3 weeks post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of patients achieving effective treatment
Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
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Clinical Cure and Mycological Cure
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1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Ron Staugaard, Medicis Pharmaceutical
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
April 25, 2011
First Submitted That Met QC Criteria
April 26, 2011
First Posted (Estimate)
April 27, 2011
Study Record Updates
Last Update Posted (Estimate)
August 28, 2013
Last Update Submitted That Met QC Criteria
August 20, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-1000-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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