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

• ClinicalTrials.gov Identifier: NCT00750139
• Recruitment Status: Completed
• First Posted: September 10, 2008
• Results First Posted: January 29, 2013
• Last Update Posted: April 26, 2013
• Sponsor: Merz North America, Inc.
• Information provided by (Responsible Party): Merz North America, Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Tinea Pedis; Athlete's Foot	Drug: NAFT-500; Drug: Placebo 2-weeks; Drug: Naftin 1%; Drug: Placebo 4-weeks	Phase 3

Detailed Description:

To evaluate the efficacy and safety of NAFT-500 compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea pedis.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 707 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel Group Evaluation of the Efficacy and Safety of NAFT-500 in Subjects With Tinea Pedis
• Study Start Date: August 2008
• Actual Primary Completion Date: August 2009
• Actual Study Completion Date: December 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Naftin 2% cream applied daily for 2 weeks	Drug: NAFT-500; topical cream 1 application every day up to 4 weeks weeks
Placebo Comparator: 2; Placebo cream applied daily for two weeks	Drug: Placebo 2-weeks; placebo cream 1 application every day for up to 4 weeks
Active Comparator: 3; Active comparator applied daily for 4 weeks	Drug: Naftin 1%; topical allylamine cream applied once a day for up to 4 weeks
Placebo Comparator: 4; placebo cream applied daily for 4 weeks	Drug: Placebo 4-weeks; topical placebo cream applied once a day for up to 4 weeks

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects With Complete Cure at Week 6. [ Time Frame: 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.

Secondary Outcome Measures :

1. Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6 [ Time Frame: Week 6 ]
   Mycological Cure was defined as negative KOH result and negative dermatophyte culture at Week 6. Treatment Effectiveness was defined as negative KOH, negative culture, and Scaling, Erythema, and Pruritus grades of 0 or 1 at Week 6.

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Review and sign a statement of Informed Consent and HIPAA authorization.
2. 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).
3. 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.
4. 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.
5. KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected or a representative site of the overall severity.
6. Subjects must be in good health and free from any clinically significant disease that might interfere with the study evaluations.
7. Subject must be able to understand the requirements of the study and willing to comply with the study requirements.

Exclusion Criteria:

1. A life-threatening condition (ex. autoimmune deficiency syndrome, cancer, unstable angina, or myocardial infarction) within the last 6 months.
2. 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.
3. Subjects with a known hypersensitivity to study medications or their components.
4. Subjects who have a recent history or who are currently known to abuse alcohol or drugs.
5. Uncontrolled diabetes mellitus.
6. Hemodialysis or chronic ambulatory peritoneal dialysis therapy.
7. Current diagnosis of immunocompromising conditions.
8. Foot psoriasis, corns and/or callus involving any web spaces, atopic or contact dermatitis.
9. Severe dermatophytoses, onychomycosis (on the evaluated foot), mucocutaneous candidiasis, or bacterial skin infection.
10. Extremely severe tinea pedis (incapacitating).
11. 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.

12. 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
    • Any other significant treatments, except hormonal contraception and multivitamin, at the discretion of the investigator that would interfere with study treatment.
    • Investigational drug within 30 days of randomization

Contacts and Locations

Locations

United States, Alabama

Radiant Research

Birmingham, Alabama, United States, 35209

United States, California

Dr. Felix Sigal

Los Angeles, California, United States, 90010-3209

University of California San Francisco, Dept of Dermatology

San Francisco, California, United States, 94115

United States, Florida

FXM Research

Miami, Florida, United States, 33175

FXM Research

Miramar, Florida, United States, 33027

United States, Illinois

Glazer Dermatology

Buffalo Grove, Illinois, United States, 60089

United States, Louisiana

Tulane University Health Services

New Orleans, Louisiana, United States, 70112

United States, Michigan

Silverton Skin Institute

Grand Blanc, Michigan, United States, 48439

United States, North Carolina

Zoe Draelos, MD

High Point, North Carolina, United States, 27262

United States, Ohio

Haber Dermatology

Euclid, Ohio, United States, 44118

United States, Oregon

Oregon Dermatology and Research Center

Portland, Oregon, United States, 97210

United States, Pennsylvania

Paddington Testing Company

Philadelphia, Pennsylvania, United States, 19103

Temple University School of Podiatric Medicine

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States, 29464

United States, Texas

J & S Studies

College Station, Texas, United States, 77845

Research Across America

Dallas, Texas, United States, 75234

Research Across America

Plano, Texas, United States, 75093

Sponsors and Collaborators

Merz North America, Inc.

Investigators

• Principal Investigator: Lawrence Parish, MD; Paddington Testing Company

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Merz North America, Inc.
• ClinicalTrials.gov Identifier: NCT00750139
• Other Study ID Numbers: MUS 90200-0736/1
• First Posted: September 10, 2008
• Results First Posted: January 29, 2013
• Last Update Posted: April 26, 2013
• Last Verified: April 2013

Keywords provided by Merz North America, Inc.:

Tinea Pedis; Athlete's foot

Additional relevant MeSH terms:

Tinea; Tinea Pedis; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Foot Dermatoses; Foot Diseases; Pruritus; Skin Manifestations