Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
NCT ID: NCT01208168
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
468 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
Vehicle alone
nail lacquer, once daily, 52 weeks
Interventions
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NAB001
nail lacquer, once daily, 52 weeks
Vehicle alone
nail lacquer, once daily, 52 weeks
Eligibility Criteria
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Inclusion Criteria
* koh positive \& dermatophyte culture positive at Visit 1
* good general health as assessed by the 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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Phoenix, Arkansas, United States
T. Joseph Raoof, MD, Inc.
Encino, California, United States
Skin Surgery Medical Group, Inc.
San Diego, California, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Internaional Dermatology Research, Inc.
Miami, Florida, United States
MedaPhase, Inc.
Newnan, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Gerard Furst, DPM, PLLC
East Setauket, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Mazur Foot and Ankle
Salisbury, North Carolina, United States
Radiant Research
Cincinnati, Ohio, United States
Oregon Dermatology & Research Network
Portland, Oregon, United States
Temple University - School of Podiatric Medicine
Philadelphia, Pennsylvania, United States
Carolina Dermatology of Greenville, PA
Greenville, South Carolina, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Ashton Podiatry Associates, PA
Dallas, Texas, United States
Progressive Clinical Research
San Antonio, Texas, United States
Instituto Dermatologica
Santo Domingo, , Dominican Republic
Instituto Dermatologico
Santo Domingo, , Dominican Republic
Countries
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Other Identifiers
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0904
Identifier Type: -
Identifier Source: org_study_id
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