Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail
- Registration Number
- NCT00453271
- Lead Sponsor
- NanoBio Corporation
- Brief Summary
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
- Detailed Description
The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 443
- are healthy males or females between the ages of 18 and 75 years of age;
- have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement;
- positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail;
- refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator;
- are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study;
- females who are pregnant, plan to become pregnant during the study, or are nursing a child;
- are hypersensitive to topical creams, ointments, medications, or surfactants;
- have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or
- have taken any investigational drug within 4 weeks prior to the start of the study.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NB-002 0.25% BID NB-002 - NB-002 0.5% QD NB-002 - NB-002 0.5% BID NB-002 - Vehicle control Vehicle control -
- Primary Outcome Measures
Name Time Method Planimetry assessment of the target great toenail Week 24 Rate of complete cure Week 46 Rate of therapeutic success Week 46
- Secondary Outcome Measures
Name Time Method Investigator's visual assessment of length of new unaffected nail The presence/absence of DSO on all toenails
Related Research Topics
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Trial Locations
- Locations (24)
International Dermatology Research
🇺🇸Miami, Florida, United States
Northwest Clinical Trial
🇺🇸Boise, Idaho, United States
Welborne Clinic
🇺🇸Evansville, Indiana, United States
Michigan Center for Research Corp.
🇺🇸Clinton Township, Michigan, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
DermResearch Inc.
🇺🇸Austin, Texas, United States
J & S Studies, Inc.
🇺🇸Bryan, Texas, United States
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