A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
NCT ID: NCT02267356
Last Updated: 2020-11-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
259 participants
INTERVENTIONAL
2015-02-17
2017-07-07
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Low dose 12-week
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
VT-1161
Low dose 24-week
2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
VT-1161
High dose 12-week
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
VT-1161
High dose 24-week
4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks
VT-1161
Placebo
4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks
Placebo
Interventions
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VT-1161
Placebo
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
70 Years
ALL
No
Sponsors
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Viamet
INDUSTRY
Responsible Party
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Locations
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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
The Skin Wellness Center
Knoxville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch
Austin, Texas, United States
J&S Clinical Studies
College Station, Texas, United States
Ashton Podiatry Associates, PA
Dallas, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
The Education And Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Countries
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References
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Elewski B, Brand S, Degenhardt T, Curelop S, Pollak R, Schotzinger R, Tavakkol A. A phase II, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of VT-1161 oral tablets in the treatment of patients with distal and lateral subungual onychomycosis of the toenail. Br J Dermatol. 2021 Feb;184(2):270-280. doi: 10.1111/bjd.19224. Epub 2020 Jul 13.
Other Identifiers
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VMT-VT-1161-CL-005
Identifier Type: -
Identifier Source: org_study_id