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

NCT ID: NCT01290341

Last Updated: 2013-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 860 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-12-31

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.

Conditions

Tinea Pedis

Keywords

fungal infection; athlete foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

NAFT-600 ( naftin 2 % gel)

Topical; applied once daily for two weeks

Group Type: EXPERIMENTAL

NAFT-600 (naftin 2 % gel)

Intervention Type: DRUG

Topical; applied once daily for two weeks

Placebo

Topical; applied once daily for two weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Topical; applied once daily for two weeks.

Interventions

NAFT-600 (naftin 2 % gel)

Topical; applied once daily for two weeks

Intervention Type: DRUG

Placebo

Topical; applied once daily for two weeks.

Intervention Type: DRUG

Other Intervention Names

Naftin®

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merz North America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrency Parrish, MD

Role: PRINCIPAL_INVESTIGATOR

Paddington Testing Co., Inc.

Locations

Radiant Research, Inc.

Tucson, Arizona, United States

T. Joseph Raoof, MD, Inc.

Encino, California, United States

Walter K. Nahm, MD, PhD, Inc.

San Diego, California, United States

Colorado Medical Research Center

Denver, Colorado, United States

Longmont Clinic, PC

Longmont, Colorado, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Lake Washington Foot and Ankle Center

Melbourne, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Hudson Dermatology

Evansville, Indiana, United States

Department of Veterans Affairs

Minneapolis, Minnesota, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Radiant Research, Inc

Cincinnati, Ohio, United States

Radiant Research, Inc.

Columbus, Ohio, United States

Oregon Dermatology & Research Center

Portland, Oregon, United States

Temple University- School of Podiatric Medicine

Philadelphia, Pennsylvania, United States

Palmetto Clinical Trial Services, LLC

Simpsonville, South Carolina, United States

DermResearch, Inc.

Austin, Texas, United States

J&S Studies, Inc.

College Station, Texas, United States

Research Across America

Dallas, Texas, United States

Endeavor Clinical Trials, PA

San Antonio, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

The Education and Research Foundation, Inc.

Lynchburg, Virginia, United States

Madison Skin and Research, Inc

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

MRZ 90200/3016/1

Identifier Type: -

Identifier Source: org_study_id