Clinical trial NCT00750139: Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tinea Pedis
Athlete's Foot
Keywords: Tinea Pedis
Athlete's foot
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 707
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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

Primary outcomes:
measure: Percentage of Subjects With Complete Cure at Week 6.
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6
timeFrame: Week 6
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research
state: Alabama
city: Los Angeles
country: United States
facility: Dr. Felix Sigal
state: California
city: San Francisco
country: United States
facility: University of California San Francisco, Dept of Dermatology
state: California
city: Miami
country: United States
facility: FXM Research
state: Florida
city: Miramar
country: United States
facility: FXM Research
state: Florida
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: New Orleans
country: United States
facility: Tulane University Health Services
state: Louisiana
city: Grand Blanc
country: United States
facility: Silverton Skin Institute
state: Michigan
city: High Point
country: United States
facility: Zoe Draelos, MD
state: North Carolina
city: Euclid
country: United States
facility: Haber Dermatology
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University School of Podiatric Medicine
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: College Station
country: United States
facility: J & S Studies
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
Study officials:
affiliation: Paddington Testing Company
name: Lawrence Parish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.