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 ]

- Summarization of AEs (local and systemic)


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