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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 855
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • Cidra, Puerto Rico, 00739
    • Advanced Medical Concepts, PSC
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Associated Foot & Ankle Specialists, LLC
  • California
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group, Inc.
    • San Francisco, California, United States, 94115
      • UCSF Dermatology Research
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center, PC
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • N. Miami Beach, Florida, United States, 33162
      • Miami Dermatology Research Institute, LLC
    • Pinellas Park, Florida, United States, 33781
      • Radiant Research, Inc.
  • Idaho
    • Boise, Idaho, United States, 83704
      • Northwest Clinical Trials
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Physician Skin Care
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Fridley, Minnesota, United States, 55432-3133
      • Minnesota Clinical Study Center
  • New York
    • Rochester, New York, United States, 14623
      • Skin Search of Rochester, Inc.
  • North Carolina
    • Salisbury, North Carolina, United States, 28144
      • Crescent Medical Research
    • Winston Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co., Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • Dermresearch, Inc.
    • Houston, Texas, United States, 77056
      • The Center for Skin Research
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials, PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• 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.
• 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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Topical; applied once daily for two weeks
Experimental: NAFT-600 ( naftin 2 % gel)	Drug: NAFT-600 ( naftin 2 % gel ); 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: Lawrence Parish, 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): January 1, 2012

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 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
• Other Study ID Numbers: MRZ 90200/3015/1