Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis
NCT ID: NCT01289015
Last Updated: 2013-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
855 participants
INTERVENTIONAL
2011-02-28
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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NAFT-600 ( naftin 2 % gel)
NAFT-600 ( naftin 2 % gel )
Topical; applied once daily for two weeks
Placebo
Placebo
Topical; applied once daily for two weeks
Interventions
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NAFT-600 ( naftin 2 % gel )
Topical; applied once daily for two weeks
Placebo
Topical; applied once daily for two weeks
Eligibility Criteria
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Inclusion Criteria
* Presence of interdigital only or both interdigital and moccasin types 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 in the affected area(s)).
Exclusion Criteria
* 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 drugs 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
12 Years
ALL
No
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 Co., Inc.
Locations
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Associated Foot & Ankle Specialists, LLC
Phoenix, Arizona, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
UCSF Dermatology Research
San Francisco, California, United States
The Savin Center, PC
New Haven, Connecticut, United States
Avail Clinical Research
DeLand, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
International Dermatology Research, Inc.
Miami, Florida, United States
Miami Dermatology Research Institute, LLC
North Miami Beach, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Northwest Clinical Trials
Boise, Idaho, United States
Physician Skin Care
Louisville, Kentucky, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
The Center for Skin Research
Houston, Texas, United States
Endeavor Clinical Trials, PA
San Antonio, Texas, United States
Advanced Medical Concepts, PSC
Cidra, PR, Puerto Rico
Countries
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Other Identifiers
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MRZ 90200/3015/1
Identifier Type: -
Identifier Source: org_study_id