A Phase 3 Double-Blind, Randomized, Placebo-Controlled,Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

NCT01289015 Phase 3 COMPLETED Results posted

The purpose of this study is to evaluate the efficacy and safety of NAFT-600, applied once daily for 2 weeks, when compared to placebo for 2 weeks in the treatment of subjects with tinea pedis.

Details

Lead sponsor	Merz North America, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	855
Start date	2011-02
Completion	2012-01

Conditions

• Tinea Pedis

Interventions

• NAFT-600 ( naftin 2 % gel )
• Placebo

Primary outcomes

• Complete Cure of Interdigital Tinea Pedis — Visit 4/ Week 6
  The primary efficacy comparison between NAFT-600 gel and placebo will be based on the percentage of subjects at Week 6 with complete cure of interdigital tinea pedis. Complete cure is defined as negative mycology results (dermatophyte culture and KOH) and the absence of erythema, scaling, and pruritus.

Countries

United States, Puerto Rico