Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

Status:	Archived
Conditions:	Podiatry
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	February 2011
End Date:	December 2011

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

This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group
Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in
the treatment of tinea pedis.

This study is open to males and non-pregnant females, 12 years of age and over, with
clinical signs and symptoms of tinea pedis consisting of at least moderate erythema,
moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects
will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse
events, concomitant medications,and study drug compliance will be reviewed at each visit.
Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms
(erythema, scaling, pruritus), and Investigator's Global Assessment.

We found this trial at

sites

Palmetto Clinical Trial Services

Greenville, South Carolina 29607

from

Greenville, SC