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

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.

Study Overview

• Status: Completed
• Conditions: Tinea Pedis
• Intervention / Treatment: Drug: NAFT-600 (naftin 2 % gel); Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 860
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85710
      • Radiant Research, Inc.
  • California
    • Encino, California, United States, 91436
      • T. Joseph Raoof, MD, Inc.
    • San Diego, California, United States, 92123
      • Walter K. Nahm, MD, PhD, Inc.
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
    • Longmont, Colorado, United States, 80501
      • Longmont Clinic, PC
  • Florida
    • Clearwater, Florida, United States, 33761
      • Tampa Bay Medical Research
    • Melbourne, Florida, United States, 32935
      • Lake Washington Foot and Ankle Center
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Department of Veterans Affairs
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45249
      • Radiant Research, Inc
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc.
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology & Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Temple University- School of Podiatric Medicine
  • South Carolina
    • Simpsonville, South Carolina, United States, 29681
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
    • Dallas, Texas, United States, 75234
      • Research Across America
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, PA
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • The Education and Research Foundation, Inc.
  • Wisconsin
    • Madison, Wisconsin, United States, 53719
      • Madison Skin and Research, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NAFT-600 ( naftin 2 % gel); Topical; applied once daily for two weeks	Drug: NAFT-600 (naftin 2 % gel); Topical; applied once daily for two weeks; Other Names: Naftin®
PLACEBO_COMPARATOR: Placebo; Topical; applied once daily for two weeks.	Drug: Placebo; Topical; applied once daily for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Merz North America, Inc.
• Investigators: Principal Investigator: Lawrency Parrish, MD, Paddington Testing Co., Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: February 3, 2011
• First Posted (ESTIMATE): February 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): September 26, 2013
• Last Update Submitted That Met QC Criteria: July 26, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: fungal infection; athlete foot
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Foot Diseases; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Skin Manifestations; Dermatomycoses; Foot Dermatoses; Pruritus; Tinea; Tinea Pedis; Anti-Infective Agents; Antifungal Agents; Naftifine
• Other Study ID Numbers: MRZ 90200/3016/1