Safety and Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
- Registration Number
- NCT01208129
- 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
- 458
- mild to moderate fungal infection of the toenail as assessed by study doctor
- koh positive & dermatophyte culture positive at Visit 1
- general good health as assessed by 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 Placebo control -
- 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)
North Florida Dermatology Association
🇺🇸Jacksonville, Florida, United States
Associated Foot & Ankle Specialists, LLC
🇺🇸Phoenix, Arkansas, United States
Radiant Research, Inc.
🇺🇸Greer, South Carolina, 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
Altus Research
🇺🇸Lake Worth, Florida, United States
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Lake Washington Foot and Ankle Center
🇺🇸Melbourne, 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
The Skin Wellness Center, PC
🇺🇸Knoxville, Tennessee, United States
Pinkas Lebovits
🇺🇸New York, New York, United States
Research Across America
🇺🇸Plano, Texas, United States
Dermatology Research Center
🇺🇸Salt Lake City, Utah, United States
Care Plus Podiatry, PC
🇺🇸Wading River, New York, United States
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Madison Skin and Research, Inc.
🇺🇸Madison, Wisconsin, United States
Coastal Podiatry, Inc.
🇺🇸Virginia Beach, Virginia, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States