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

Tinea Pedis Clinical Trial

— NAFT-600  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289015
• Other study ID #: MRZ 90200/3015/1
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2011
• Last updated: July 26, 2013
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2013
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 855
• Est. completion date: January 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Males or non-pregnant females, =12 years of age, of any race or sex. Females of child-bearing potential must have a negative urine pregnancy test.

• Presence of interdigital only or both interdigital and moccasin types of tinea pedis on one or both feet characterized by clinical evidence of a tinea infection (at least moderate erythema, moderate scaling and mild pruritus) based on signs and symptoms in the affected area(s)).

Exclusion Criteria:

• Subjects with life-threatening condition (ex. autoimmune deficiency syndrome, cancer,unstable angina or myocardial infarction) within the last 6 months.

• Subjects with abnormal findings - physical or laboratory - that are considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.

• Subjects with a known hypersensitivity to study drugs or their components.

• Subjects who have a recent history or who are currently known to abuse alcohol or drugs.

• Uncontrolled diabetes mellitus.

• Hemodialysis or chronic ambulatory peritoneal dialysis therapy.

• Current diagnosis of immunocompromising conditions.

• Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.

• Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis or bacterial skin infection.

• Extremely severe tinea pedis (incapacitating).

• Female subject who is pregnant or lactating, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinea
• Tinea Pedis

Intervention

Drug:
• NAFT-600 ( naftin 2 % gel )
Topical; applied once daily for two weeks
• Placebo
Topical; applied once daily for two weeks

Locations

Country	Name	City	State
Puerto Rico	Advanced Medical Concepts, PSC	Cidra
United States	DermResearch, Inc.	Austin	Texas
United States	Northwest Clinical Trials	Boise	Idaho
United States	Michigan Center for Skin Care Research	Clinton Township	Michigan
United States	Avail Clinical Research	DeLand	Florida
United States	Henry Ford Hospital	Detroit	Michigan
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	The Center for Skin Research	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Physician Skin Care	Louisville	Kentucky
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Miami Dermatology Research Institute, LLC	N. Miami Beach	Florida
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	The Savin Center, PC	New Haven	Connecticut
United States	Paddington Testing Co., Inc.	Philadelphia	Pennsylvania
United States	Associated Foot & Ankle Specialists, LLC	Phoenix	Arizona
United States	Radiant Research, Inc.	Pinellas Park	Florida
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	Crescent Medical Research	Salisbury	North Carolina
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc.	San Diego	California
United States	UCSF Dermatology Research	San Francisco	California
United States	Wake Forest University Health Sciences	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Cure of Interdigital Tinea Pedis	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.	Visit 4/ Week 6	No
Secondary	Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6	Effective treatment of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture and erythema, scaling, and pruritus scores of 0 or 1 (corresponding to absent and mild respectively).; Mycological cure of interdigital tinea pedis which is defined as negative KOH and negative dermatophyte culture.	Visit 4/ Week 6.	No