Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
Lead Sponsor:
Viamet
Conditions:
Onychomycosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Key
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2017
Estimated Enrollment :
259 Patients enrolled
Trial Details
Trial ID
NCT02267356
Start Date
February 17 2015
End Date
July 7 2017
Last Update
November 4 2020
Active Locations (33)
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1
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, United States, 35233
2
Radiant Research
Tucson, Arizona, United States, 85712
3
Dermatology Specialists, Inc
Oceanside, California, United States, 92056
4
Therapeutics Clinical Research
San Diego, California, United States, 92123