Clinical Trial: Evaluation of Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of Naftin 1% Cream in Adolescent Subjects With Tinea Cruris
Brief Summary: To see how well Naftin 1% cream works when applied once daily to the affected area. The results will be compared to those using a placebo cream, which is a cream with no active ingredient. Safety will also be measured.
Detailed Summary:
Sponsor: Merz Pharmaceuticals, LLC
Current Primary Outcome: Safety of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). [ Time Frame: Week 6 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Efficacy of Naftin® 1% Cream, applied once daily for 4 weeks, compared to vehicle for treatment of subjects with KOH and culture positive symptomatic tinea cruris in adolescent subjects (aged 12 years to 17 years, 11 months). [ Time Frame: Week 6 ]
Complete Cure based on:
-Negative mycology results; absence (Grade 0) of erythema, scaling, and pruritis
Other efficacy variables assessed at Week 2, Week 4, and Week 6:
- Effective treatment
- Mycological cure
- Clinical Success
- Clinical Cure
- Investigator Global Assessment
- Subject Satisfaction Assessment
Original Secondary Outcome: Same as current
Information By: Merz Pharmaceuticals, LLC
Dates:
Date Received: June 20, 2013
Date Started: August 2013
Date Completion:
Last Updated: March 26, 2015
Last Verified: March 2015