Topical Antifungal Treatment for Tinea Cruris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicis Global Service Corporation
ClinicalTrials.gov Identifier:
NCT01342315
First received: April 25, 2011
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

  • pregnancy and allergies
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342315

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

No publications provided

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01342315     History of Changes
Other Study ID Numbers: MP-1000-01
Study First Received: April 25, 2011
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014