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

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 3
Locations
International
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.
  • 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

  • Associated Foot & Ankle Specialists, LLC
  • Skin Surgery Medical Group, Inc.
  • UCSF Dermatology Research
  • The Savin Center, PC
  • Avail Clinical Research
  • Jacksonville Center for Clinical Research
  • International Dermatology Research, Inc.
  • Miami Dermatology Research Institute, LLC
  • Radiant Research, Inc.
  • Northwest Clinical Trials
  • Physician Skin Care
  • Michigan Center for Skin Care Research
  • Henry Ford Hospital
  • Minnesota Clinical Study Center
  • Skin Search of Rochester, Inc.
  • Crescent Medical Research
  • Wake Forest University Health Sciences
  • Paddington Testing Co., Inc.
  • Tennessee Clinical Research Center
  • DermResearch, Inc.
  • The Center for Skin Research
  • Endeavor Clinical Trials, PA
  • Advanced Medical Concepts, PSC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NAFT-600 ( naftin 2 % gel)

Placebo

Arm Description

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
NCT01289015
Brief Title
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
January 2012 (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
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.

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
855 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAFT-600 ( naftin 2 % gel)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
NAFT-600 ( naftin 2 % gel )
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. 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
Lawrence Parish, MD
Organizational Affiliation
Paddington Testing Co., Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associated Foot & Ankle Specialists, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Skin Surgery Medical Group, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
UCSF Dermatology Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
The Savin Center, PC
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Avail Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
International Dermatology Research, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Miami Dermatology Research Institute, LLC
City
N. Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Radiant Research, Inc.
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Facility Name
Northwest Clinical Trials
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Physician Skin Care
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Michigan Center for Skin Care Research
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432-3133
Country
United States
Facility Name
Skin Search of Rochester, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Crescent Medical Research
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Paddington Testing Co., Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Endeavor Clinical Trials, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Advanced Medical Concepts, PSC
City
Cidra
ZIP/Postal Code
00739
Country
Puerto Rico

12. IPD Sharing Statement

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

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