A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
- Registration Number
- NCT02267356
- Lead Sponsor
- Viamet
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 259
Distal subungual onychomycosis of the great toenail, affecting at least ≥25 to ≤75% of nail.
Positive culture for dermatophytes and positive KOH.
Nail ≤ 3 mm thick at the distal end.
At least ≥ 2 mm of the proximal end of the great toenail must be free of infection.
Subjects must be able to swallow tablets.
Women of childbearing potential and males must use acceptable birth control methods throughout the study.
Key
Presence of subungual hematoma or melanonychia.
Presence of dermatophytoma/nail streaks and severe onychorrhexis.
Significant dystrophy or anatomic abnormalities of the great toenail.
Presence of any other infections of the foot.
Evidence of clinically significant major organ disease.
Poorly controlled diabetes mellitus.
Onychomycosis involving more than 8 toe nails.
Recent use of systemic antifungal therapy.
Recent of any topical antifungal nail therapy.
Recent use of systemic corticosteroid therapy.
Recent use of immunosuppressive medication.
History of prolonged QT intervals.
Known human immunodeficiency virus (HIV) infection.
Known significant renal or hepatic impairment.
Known history of intolerance or hypersensitivity to azole antifungal drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks Low dose 24-week VT-1161 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks High dose 12-week VT-1161 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks High dose 24-week VT-1161 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks Low dose 12-week VT-1161 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 10 weeks, followed by 4 placebo tablets once weekly for 12 weeks
- Primary Outcome Measures
Name Time Method The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48 48 weeks Complete cure was defined as 0% nail involvement and an Investigator Global Assessment (IGA) score of 0. Mycological cure was defined as negative potassium hydroxide (KOH) and negative dermatophyte culture.
Investigator Global Assessment (IGA) scoring:
0: 0% nail involvement
1. \>0% to ≤10% nail involvement
2. \>10% to \<25% nail involvement
3. ≥25% to ≤50% nail involvement
4. \>50% to ≤75% nail involvement
5. \>75% nail involvementStudy Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities 9 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
DermResearch
🇺🇸Austin, Texas, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
International Dermatology Research
🇺🇸Miami, Florida, United States
Mid Atlantic Research Center for Health
🇺🇸Baltimore, Maryland, United States
Paddington Testing Company
🇺🇸Philadelphia, Pennsylvania, United States
The Kirklin Clinic of UAB Hospital
🇺🇸Birmingham, Alabama, United States
Center For Clinical Research
🇺🇸San Francisco, California, United States
Oregon Dermatology & Research Center
🇺🇸Portland, Oregon, United States
Associated Skin Care Specialist Minnesota Clinical Study Center
🇺🇸Minneapolis, Minnesota, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Endeavor Clinical Trials
🇺🇸San Antonio, Texas, United States
Dermatology Specialists, Inc
🇺🇸Oceanside, California, United States
Gateway Health Center
🇺🇸Newburgh, Indiana, United States
Forest Hills Dermatology Group
🇺🇸Forest Hills, New York, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
J&S Clinical Studies
🇺🇸College Station, Texas, United States
Ashton Podiatry Associates, PA
🇺🇸Dallas, Texas, United States
The Education And Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Northwest Clinical Trials
🇺🇸Boise, Idaho, United States
Skin Search of Rochester
🇺🇸Rochester, New York, United States
Martin Foot and Ankle
🇺🇸York, Pennsylvania, United States
Radiant Research
🇺🇸Greer, South Carolina, United States