Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis
NCT ID: NCT00750139
Last Updated: 2013-04-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
707 participants
INTERVENTIONAL
2008-08-31
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Naftin 2% cream applied daily for 2 weeks
NAFT-500
topical cream 1 application every day up to 4 weeks weeks
2
Placebo cream applied daily for two weeks
Placebo 2-weeks
placebo cream 1 application every day for up to 4 weeks
3
Active comparator applied daily for 4 weeks
Naftin 1%
topical allylamine cream applied once a day for up to 4 weeks
4
placebo cream applied daily for 4 weeks
Placebo 4-weeks
topical placebo cream applied once a day for up to 4 weeks
Interventions
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NAFT-500
topical cream 1 application every day up to 4 weeks weeks
Placebo 2-weeks
placebo cream 1 application every day for up to 4 weeks
Naftin 1%
topical allylamine cream applied once a day for up to 4 weeks
Placebo 4-weeks
topical placebo cream applied once a day for up to 4 weeks
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
ALL
Yes
Sponsors
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Merz North America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence Parish, MD
Role: PRINCIPAL_INVESTIGATOR
Paddington Testing Company
Locations
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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
Countries
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References
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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.
Other Identifiers
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MUS 90200-0736/1
Identifier Type: -
Identifier Source: org_study_id
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