Evaluation of the 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: NCT01290341
• Other study ID #: MRZ 90200/3016/1
• Status: Completed
• Phase: Phase 3
• First received: January 28, 2011
• Last updated: July 26, 2013
• Start date: February 2011
• Est. completion date: December 2011

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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 860
• Est. completion date: December 2011
• 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.

• For minors (less than 18 years), the parent/legal guardian must complete the informed consent process AND the subject must complete the assent process and sign the appropriate form (if age appropriate).

• 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
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	Radiant Research, Inc	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	J&S Studies, Inc.	College Station	Texas
United States	Radiant Research, Inc.	Columbus	Ohio
United States	Research Across America	Dallas	Texas
United States	Colorado Medical Research Center	Denver	Colorado
United States	T. Joseph Raoof, MD, Inc.	Encino	California
United States	Hudson Dermatology	Evansville	Indiana
United States	Longmont Clinic, PC	Longmont	Colorado
United States	The Education and Research Foundation, Inc.	Lynchburg	Virginia
United States	Madison Skin and Research, Inc	Madison	Wisconsin
United States	Lake Washington Foot and Ankle Center	Melbourne	Florida
United States	Department of Veterans Affairs	Minneapolis	Minnesota
United States	Temple University- School of Podiatric Medicine	Philadelphia	Pennsylvania
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Endeavor Clinical Trials, PA	San Antonio	Texas
United States	Progressive Clinical Research	San Antonio	Texas
United States	Walter K. Nahm, MD, PhD, Inc.	San Diego	California
United States	Palmetto Clinical Trial Services, LLC	Simpsonville	South Carolina
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Radiant Research, Inc.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

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