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Topical Antifungal Treatment for Tinea Cruris

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tinea Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01342315
First received: April 25, 2011
Last updated: January 22, 2013
Last verified: January 2013
History of Changes
  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:

MedlinePlus related topics: Tinea Infections
U.S. FDA Resources

Further study details as provided by Tinea Pharmaceuticals:

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

  Show 21 Study Locations
Sponsors and Collaborators
Tinea Pharmaceuticals
  More Information

No publications provided

Responsible Party: Tinea Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01342315     History of Changes
Other Study ID Numbers: MP-1000-01
Study First Received: April 25, 2011
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Tinea Pharmaceuticals:
Tinea Cruris, antifungal

Additional relevant MeSH terms:
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
 Skin Diseases
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013