Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
NCT ID: NCT01208129
Last Updated: 2013-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
458 participants
INTERVENTIONAL
2010-09-30
2012-07-31
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
QUADRUPLE
Study Groups
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Active drug
NAB001
nail lacquer, once daily, 52 weeks
Vehicle alone
Placebo control
nail lacquer, once daily, 52 weeks
Interventions
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NAB001
nail lacquer, once daily, 52 weeks
Placebo control
nail lacquer, once daily, 52 weeks
Eligibility Criteria
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Inclusion Criteria
* koh positive \& dermatophyte culture positive at Visit 1
* general good health as assessed by study doctor
Exclusion Criteria
* prior use of antifungal drugs (wash-out allowed, duration varies on class)
* significant confounding conditions as assessed by study doctor
* pregnancy/lactation
* must forego nail salon procedures during study for at least \~60 weeks
18 Years
70 Years
ALL
No
Sponsors
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Promius Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Kent Allenby, MD
Role: STUDY_DIRECTOR
Promius Pharma
Joanne Fraser, PhD
Role: STUDY_DIRECTOR
Promius Pharma
Locations
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Radiant Research, Inc.
Tucson, Arizona, United States
Associated Foot & Ankle Specialists, LLC
Phoenix, Arkansas, United States
Family Foot Health Center
Rogers, Arkansas, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
UCSF Dermatology Research
San Francisco, California, United States
Avail Clinical Research
DeLand, Florida, United States
North Florida Dermatology Association
Jacksonville, Florida, United States
Altus Research
Lake Worth, Florida, United States
Lake Washington Foot and Ankle Center
Melbourne, Florida, United States
Park Avenue Dermatology
Orange Park, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
Deaconess Clinic Downtown
Evansville, Indiana, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Department of Veteran's Affairs
Minneapolis, Minnesota, United States
Pinkas Lebovits
New York, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Care Plus Podiatry, PC
Wading River, New York, United States
Oregon Medical Research Center, PC
Portland, Oregon, United States
Radiant Research, Inc.
Greer, South Carolina, United States
The Skin Wellness Center, PC
Knoxville, Tennessee, United States
Research Across America
Plano, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Dermatology Research Center
Salt Lake City, Utah, United States
Coastal Podiatry, Inc.
Virginia Beach, Virginia, United States
Madison Skin and Research, Inc.
Madison, Wisconsin, United States
Countries
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Other Identifiers
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0903
Identifier Type: -
Identifier Source: org_study_id
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