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

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
NAFT-600 (naftin 2 % gel)
Placebo
Sponsored by
Merz North America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring fungal infection, athlete foot

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Radiant Research, Inc.
  • T. Joseph Raoof, MD, Inc.
  • Walter K. Nahm, MD, PhD, Inc.
  • Colorado Medical Research Center
  • Longmont Clinic, PC
  • Tampa Bay Medical Research
  • Lake Washington Foot and Ankle Center
  • Clinical Research Atlanta
  • Hudson Dermatology
  • Department of Veterans Affairs
  • Academic Dermatology Associates
  • Radiant Research, Inc
  • Radiant Research, Inc.
  • Oregon Dermatology & Research Center
  • Temple University- School of Podiatric Medicine
  • Palmetto Clinical Trial Services, LLC
  • DermResearch, Inc.
  • J&S Studies, Inc.
  • Research Across America
  • Endeavor Clinical Trials, PA
  • Progressive Clinical Research
  • The Education and Research Foundation, Inc.
  • Madison Skin and Research, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NAFT-600 ( naftin 2 % gel)

Placebo

Arm Description

Topical; applied once daily for two weeks

Topical; applied once daily for two weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 28, 2011
Last Updated
July 26, 2013
Sponsor
Merz North America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01290341
Brief Title
Evaluation of the Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz North America, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinea Pedis
Keywords
fungal infection, athlete foot

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
860 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAFT-600 ( naftin 2 % gel)
Arm Type
Experimental
Arm Description
Topical; applied once daily for two weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical; applied once daily for two weeks.
Intervention Type
Drug
Intervention Name(s)
NAFT-600 (naftin 2 % gel)
Other Intervention Name(s)
Naftin®
Intervention Description
Topical; applied once daily for two weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical; applied once daily for two weeks.
Primary Outcome Measure Information:
Title
Complete Cure of Interdigital Tinea Pedis
Description
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.
Time Frame
Visit 4/ Week 6
Secondary Outcome Measure Information:
Title
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6
Description
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.
Time Frame
Visit 4/ Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrency Parrish, MD
Organizational Affiliation
Paddington Testing Co., Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiant Research, Inc.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
T. Joseph Raoof, MD, Inc.
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Walter K. Nahm, MD, PhD, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Colorado Medical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Longmont Clinic, PC
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Lake Washington Foot and Ankle Center
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Hudson Dermatology
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Department of Veterans Affairs
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Radiant Research, Inc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Radiant Research, Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Oregon Dermatology & Research Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Temple University- School of Podiatric Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Palmetto Clinical Trial Services, LLC
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
The Education and Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Madison Skin and Research, Inc
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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