A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Completed · Phase 2 · Has a placebo group
Conditions studied: Onychomycosis
In brief
Several properties of VT-1161 suggest that it might be a safer and more effective treatment for onychomycosis of the toenail (also known as toenail fungus) than other oral antifungal medicines. This study will evaluate the effectiveness and safety of VT-1161 for the treatment of toenail onychomycosis and consists of a screening phase, a 24-week treatment phase in which the patient will take either active drug, placebo or a combination of the 2 (according to random assignment), an initial observational phase of 36 weeks and an additional observational study extension of 9 months. The additional 9-month observational study extension was added with a protocol amendment and patient participation was optional.
Key facts
- Study ID
- NCT02267356
- Run by
- Viamet
- People needed
- 259
- Starts
- 2015-02-17
- Expected to finish
- 2017-07-07
- Last updated by the study team
- 2020-11-04
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Kirklin Clinic of UAB Hospital — Birmingham, Alabama, United States
- Radiant Research — Tucson, Arizona, United States
- Dermatology Specialists, Inc — Oceanside, California, United States
- Therapeutics Clinical Research — San Diego, California, United States
- Center For Clinical Research — San Francisco, California, United States
- Radiant Research — Santa Rosa, California, United States
- International Dermatology Research — Miami, Florida, United States
- Radiant Research — Pinellas Park, Florida, United States
- Northwest Clinical Trials — Boise, Idaho, United States
- Gateway Health Center — Newburgh, Indiana, United States
- Mid Atlantic Research Center for Health — Baltimore, Maryland, United States
- Associated Skin Care Specialist Minnesota Clinical Study Center — Minneapolis, Minnesota, United States
- Skin Specialists, PC — Omaha, Nebraska, United States
- Academic Dermatology Associates — Albuquerque, New Mexico, United States
- Forest Hills Dermatology Group — Forest Hills, New York, United States
- Skin Search of Rochester — Rochester, New York, United States
- Radiant Research — Akron, Ohio, United States
- Radiant Research — Cincinnati, Ohio, United States
- Radiant Research — Columbus, Ohio, United States
- Oregon Dermatology & Research Center — Portland, Oregon, United States
- Oregon Medical Research Center — Portland, Oregon, United States
- Paddington Testing Company — Philadelphia, Pennsylvania, United States
- Martin Foot and Ankle — York, Pennsylvania, United States
- Radiant Research — Greer, South Carolina, United States
- Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
Full record on ClinicalTrials.gov
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