Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
- Registration Number
- NCT01208168
- Lead Sponsor
- Promius Pharma, LLC
- Brief Summary
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 468
- mild to moderate fungal infection of the toenail as assessed by study doctor
- koh positive & dermatophyte culture positive at Visit 1
- good general health as assessed by the study doctor
- severe fungal toenail infection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active drug NAB001 - Vehicle alone Vehicle alone -
- Primary Outcome Measures
Name Time Method Complete cure rate at Week 56. Complete cure defined as clinically clear nail and mycological cure. Week 56 after 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method Proportion of subjects with effective treatment at week 56. Effective treatment defined as mycological cure and an IGA of 0 or 1 (Clear or almost clear). Week 56
Trial Locations
- Locations (23)
Internaional Dermatology Research, Inc.
🇺🇸Miami, Florida, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Skin Surgery Medical Group, Inc.
🇺🇸San Diego, California, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, 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
Temple University - School of Podiatric Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Mazur Foot and Ankle
🇺🇸Salisbury, North Carolina, United States
Carolina Dermatology of Greenville, PA
🇺🇸Greenville, South Carolina, United States
Ashton Podiatry Associates, PA
🇺🇸Dallas, Texas, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Instituto Dermatologica
🇩🇴Santo Domingo, Dominican Republic
Instituto Dermatologico
🇩🇴Santo Domingo, Dominican Republic
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
T. Joseph Raoof, MD, Inc.
🇺🇸Encino, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Oregon Dermatology & Research Network
🇺🇸Portland, Oregon, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Radiant Research
🇺🇸Cincinnati, Ohio, United States