Topical Antifungal Treatment for Tinea Cruris

Phase 3

Completed

• Conditions: Tinea Cruris
• Interventions: Drug: 33525; Drug: Placebo

• Registration Number: NCT01342315
• Lead Sponsor: Medicis Global Service Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-26
• Study First Posted: 2011-04-27
• Study Start: 2011-05
• Primary Completion: 2012-03
• Study Completion: 2012-05
• Disposition First Submitted: 2013-01-22
• Disposition First Submitted QC: 2013-01-22
• Disposition First Posted: 2013-01-23
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-20
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 483

Inclusion Criteria

• moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria

• pregnancy and allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	33525	Product 33525
Placebo	Placebo	Product 33525 Placebo

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving complete clearance	3 weeks post-treatment	Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture

Secondary Outcome Measures

Name	Time	Method
Proportion of patients achieving effective treatment	1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment	Clinical Cure and Mycological Cure