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

Completed · Phase 3 · Has a placebo group

Conditions studied: Tinea Pedis, Athlete's Foot

In brief

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).

Key facts

Study ID

NCT00750139

Run by

Merz North America, Inc.

People needed

707

Starts

2008-08-01

Expected to finish

2009-12-01

Last updated by the study team

2013-04-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Radiant Research — Birmingham, Alabama, United States
• Dr. Felix Sigal — Los Angeles, California, United States
• University of California San Francisco, Dept of Dermatology — San Francisco, California, United States
• FXM Research — Miami, Florida, United States
• FXM Research — Miramar, Florida, United States
• Glazer Dermatology — Buffalo Grove, Illinois, United States
• Tulane University Health Services — New Orleans, Louisiana, United States
• Silverton Skin Institute — Grand Blanc, Michigan, United States
• Zoe Draelos, MD — High Point, North Carolina, United States
• Haber Dermatology — Euclid, Ohio, United States
• Oregon Dermatology and Research Center — Portland, Oregon, United States
• Paddington Testing Company — Philadelphia, Pennsylvania, United States
• Temple University School of Podiatric Medicine — Philadelphia, Pennsylvania, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• J & S Studies — College Station, Texas, United States
• Research Across America — Dallas, Texas, United States
• Research Across America — Plano, Texas, United States

Full record on ClinicalTrials.gov

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