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 ]
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) ]
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