We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Antifungal Treatment for Tinea Cruris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01342315
First Posted: April 27, 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
  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
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

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

  • pregnancy and allergies
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01342315


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

Responsible Party: Medicis Global Service Corporation
ClinicalTrials.gov Identifier: NCT01342315     History of Changes
Other Study ID Numbers: MP-1000-01
First Submitted: April 25, 2011
First Posted: April 27, 2011
Last Update Posted: August 28, 2013
Last Verified: August 2013

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

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