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Topical Antifungal Treatment for Tinea Cruris

This study has been completed.
Information provided by (Responsible Party):
Medicis Global Service Corporation Identifier:
First received: April 25, 2011
Last updated: August 20, 2013
Last verified: August 2013
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris

Condition Intervention Phase
Tinea Cruris
Drug: 33525
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

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: 3 weeks post-treatment ]
    Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures:
  • 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

Enrollment: 483
Study Start Date: May 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Product 33525
Drug: 33525
Daily dosing
Experimental: Placebo
Product 33525 Placebo
Drug: Placebo
Daily dosing


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

Inclusion Criteria:

  • moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

  • pregnancy and allergies
  Contacts and Locations
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Please refer to this study by its identifier: NCT01342315

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

Responsible Party: Medicis Global Service Corporation Identifier: NCT01342315     History of Changes
Other Study ID Numbers: MP-1000-01
Study First Received: April 25, 2011
Last Updated: August 20, 2013

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

Additional relevant MeSH terms:
Skin Diseases, Infectious
Skin Diseases processed this record on May 22, 2017