Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

NCT00750139 | Completed Phase 3 Results

• 1 other identifier: MUS 90200-0736/1
• Study Type: interventional
• Target: 707
• Locations: 1 country
• Sites: 17

Brief Summary

A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo, when used in subjects with tinea pedis (athlete's foot).

Conditions

Tinea Pedis; Athlete's Foot

Keywords

Tinea Pedis; Athlete's foot

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Complete Cure at Week 6.

  The first primary efficacy variable was the percentage of subjects in the NAFT-500 Cream, 2% or 2-week placebo groups with complete cure at Week 6. The second primary efficacy variable was the percentage of subjects in the Naftin 1% Cream or 4-week placebo groups with complete cure at Week 6. Complete cure was defined as negative mycology results from the central laboratory (dermatophyte culture and KOH) and absence of erythema, scaling, and pruritus that were evaluated using a 4 point severity scale.

  Week 6

Secondary Outcomes (1)

• Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6

  Week 6

Study Arms (4)

1

EXPERIMENTAL

Naftin 2% cream applied daily for 2 weeks

Drug: NAFT-500

2

PLACEBO COMPARATOR

Placebo cream applied daily for two weeks

Drug: Placebo 2-weeks

3

ACTIVE COMPARATOR

Active comparator applied daily for 4 weeks

Drug: Naftin 1%

4

PLACEBO COMPARATOR

placebo cream applied daily for 4 weeks

Drug: Placebo 4-weeks

Interventions

NAFT-500 DRUG

topical cream 1 application every day up to 4 weeks weeks

1

Placebo 2-weeks DRUG

placebo cream 1 application every day for up to 4 weeks

2

Naftin 1% DRUG

topical allylamine cream applied once a day for up to 4 weeks

3

Placebo 4-weeks DRUG

topical placebo cream applied once a day for up to 4 weeks

4

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Review and sign a statement of Informed Consent and HIPAA authorization.
• 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).
• Males or non-pregnant females ≥12 years of age, of any race or sex. Females of childbearing potential must have a negative urine pregnancy test.
• Presence 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.
• KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
• Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
• Subject must be able to understand the requirements of the study and willing to comply with the study requirements.

You may not qualify if:

• A 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 medications 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 (females who are surgically sterilized or post menopausal for at least 2 years are not considered to be of childbearing potential).For the purposes of this study, acceptable forms of birth control include: oral contraceptives, contraceptive patches/implants, double barrier methods (e.g., use of condom and spermicide), IUD, and abstinence with second acceptable method should subject become sexually active.
• Subjects using the following medications:
• Topical anti-fungal therapy, foot/shoe powders, or topical corticosteroids applied to the feet within 14 days prior to randomization. Topical terbinafine, butenafine,and naftifine within 30 days prior to randomization
• Oral anti-fungal therapies 3 months (8 months for oral terbinafine) prior to randomization
• Systemic antibiotic or corticosteroid treatment within 30 days of randomization

Sponsors & Collaborators

• Merz North America, Inc.: lead

Study Sites (17)

Radiant Research

Birmingham, Alabama, 35209, United States

Location

Dr. Felix Sigal

Los Angeles, California, 90010-3209, United States

Location

University of California San Francisco, Dept of Dermatology

San Francisco, California, 94115, United States

Location

FXM Research

Miami, Florida, 33175, United States

Location

FXM Research

Miramar, Florida, 33027, United States

Location

Glazer Dermatology

Buffalo Grove, Illinois, 60089, United States

Location

Tulane University Health Services

New Orleans, Louisiana, 70112, United States

Location

Silverton Skin Institute

Grand Blanc, Michigan, 48439, United States

Location

Zoe Draelos, MD

High Point, North Carolina, 27262, United States

Location

Haber Dermatology

Euclid, Ohio, 44118, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

Paddington Testing Company

Philadelphia, Pennsylvania, 19103, United States

Location

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, 29464, United States

Location

J & S Studies

College Station, Texas, 77845, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Related Publications (1)

• Parish LC, Parish JL, Routh HB, Fleischer AB Jr, Avakian EV, Plaum S, Hardas B. A randomized, double-blind, vehicle-controlled efficacy and safety study of naftifine 2% cream in the treatment of tinea pedis. J Drugs Dermatol. 2011 Nov;10(11):1282-8.

  PMID: 22052309 DERIVED

MeSH Terms

Conditions

Tinea Pedis

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Associate Medical Director- Dermatology
• Organization: Merz Pharmaceuticals, LLC

800-334-0514

Study Officials

• Lawrence Parish, MD

  Paddington Testing Company

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 10, 2008
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 26, 2013
• Results First Posted: January 29, 2013

Record last verified: 2013-04

Locations

US (17)