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

Phase 3

Completed

• Conditions: Tinea Pedis
• Interventions: Drug: Placebo; Drug: NAFT-600 ( naftin 2 % gel )

• Registration Number: NCT01289015
• Lead Sponsor: Merz North America, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-28
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Primary Completion: 2011-11
• Study Completion: 2012-01
• Disposition First Submitted: 2013-04-15
• Disposition First Submitted QC: 2013-04-15
• Disposition First Posted: 2013-04-23
• Status Verified: 2013-07
• Results First Submitted: 2013-07-26
• Results First Submitted QC: 2013-07-26
• Last Update Submitted: 2013-07-26
• Results First Posted: 2013-09-26
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 855

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
NAFT-600 ( naftin 2 % gel)	NAFT-600 ( naftin 2 % gel )	-

Primary Outcome Measures

Name	Time	Method
Complete Cure of Interdigital Tinea Pedis	Visit 4/ Week 6	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

Name	Time	Method
Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6	Visit 4/ 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.

Trial Locations

Locations (23)

International Dermatology Research, Inc.; 🇺🇸 Miami, Florida, United States

Northwest Clinical Trials; 🇺🇸 Boise, Idaho, United States

UCSF Dermatology Research; 🇺🇸 San Francisco, California, United States

Avail Clinical Research; 🇺🇸 DeLand, Florida, United States

Jacksonville Center for Clinical Research; 🇺🇸 Jacksonville, Florida, United States

Miami Dermatology Research Institute, LLC; 🇺🇸 N. Miami Beach, Florida, United States

Radiant Research, Inc.; 🇺🇸 Pinellas Park, Florida, United States

Physician Skin Care; 🇺🇸 Louisville, Kentucky, United States

Michigan Center for Skin Care Research; 🇺🇸 Clinton Township, Michigan, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Skin Search of Rochester, Inc.; 🇺🇸 Rochester, New York, United States

Crescent Medical Research; 🇺🇸 Salisbury, North Carolina, United States

Paddington Testing Co., Inc.; 🇺🇸 Philadelphia, Pennsylvania, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

The Center for Skin Research; 🇺🇸 Houston, Texas, United States

Endeavor Clinical Trials, PA; 🇺🇸 San Antonio, Texas, United States

Skin Surgery Medical Group, Inc.; 🇺🇸 San Diego, California, United States

The Savin Center, PC; 🇺🇸 New Haven, Connecticut, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States

Advanced Medical Concepts, PSC; 🇵🇷 Cidra, Puerto Rico

Associated Foot & Ankle Specialists, LLC; 🇺🇸 Phoenix, Arizona, United States

Wake Forest University Health Sciences; 🇺🇸 Winston Salem, North Carolina, United States