Topical Antifungal Treatment for Tinea Cruris

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. Identifier: NCT01342315
Recruitment Status : Completed
First Posted : April 27, 2011
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Medicis Global Service Corporation

Brief Summary:
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris

Condition or disease Intervention/treatment Phase
Tinea Cruris Drug: 33525 Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 483 participants
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 Cruris
Study Start Date : May 2011
Actual Primary Completion Date : March 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinea Infections

Arm Intervention/treatment
Experimental: Active
Product 33525
Drug: 33525
Daily dosing

Experimental: Placebo
Product 33525 Placebo
Drug: Placebo
Daily dosing

Primary Outcome Measures :
  1. Proportion of patients achieving complete clearance [ Time Frame: 3 weeks post-treatment ]
    Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures :
  1. Proportion of patients achieving effective treatment [ Time Frame: 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment ]
    Clinical Cure and Mycological Cure

Information from the National Library of Medicine

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

Inclusion Criteria:

  • moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

  • pregnancy and allergies

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 identifier (NCT number): NCT01342315

  Show 21 Study Locations
Sponsors and Collaborators
Medicis Global Service Corporation
Study Director: Ron Staugaard Medicis Pharmaceutical

Responsible Party: Medicis Global Service Corporation Identifier: NCT01342315     History of Changes
Other Study ID Numbers: MP-1000-01
First Posted: April 27, 2011    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Keywords provided by Medicis Global Service Corporation:
Tinea Cruris, antifungal

Additional relevant MeSH terms:
Skin Diseases, Infectious
Skin Diseases