Clinical Trial: Multicenter Study of the Safety and Efficacy of NAFT-500 in 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 NAFT-500 in Subjects With Tinea Cruris

Brief Summary: A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.

Detailed Summary: To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.
Sponsor: Merz Pharmaceuticals, LLC

Current Primary Outcome: Percentage of Subjects [ Time Frame: Week 4 post-baseline ]

Complete cure is defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of Erythema, Scaling, and Pruritus (grade 0 for each) evaluated using the 5-point severity grading scale: 0 = absent, 1 = mild, 2 = moderate, 3 = marked, and 4 = not done.


Original Primary Outcome: the percentage of subjects at the 2 week time point post treatment with complete cure defined as negative mycology results from the central laboratory (dermatophyte culture, KOH and Physicians Global Evaluation score of 1). [ Time Frame: two weeks post treatment ]

Current Secondary Outcome: Mycological Cure and Treatment Effectiveness [ Time Frame: Week 4 (two weeks post-treatment) ]

Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 4. Treatment Effectiveness as defined as negative KOH, negative culture, and Scaling, Erythema and Pruritis grades of 0 or 1 at Week 4.


Original Secondary Outcome: Mycological Cure;Clinical Cure;Clinical Success;Physicians Global Evaluation; Subject Satisfaction Assessment [ Time Frame: two weeks post treatment ]

Information By: Merz Pharmaceuticals, LLC

Dates:
Date Received: September 9, 2008
Date Started: September 2008
Date Completion:
Last Updated: April 15, 2013
Last Verified: October 2012