A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail

Onychomycosis Clinical Trial

Official title:

A Phase 2, 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 Lateral Subungual Onychomycosis of the Toenail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267356
• Other study ID #: VMT-VT-1161-CL-005
• Status: Completed
• Phase: Phase 2
• Start date: February 17, 2015
• Est. completion date: July 7, 2017

Study information

• Verified date: October 2020
• Source: Viamet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: July 7, 2017
• Est. primary completion date: October 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

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 Criteria:

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.

Related Conditions & MeSH terms

• Onychomycosis

Intervention

Drug:
• VT-1161

• Placebo

Locations

Country	Name	City	State
United States	Radiant Research	Akron	Ohio
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch	Austin	Texas
United States	Mid Atlantic Research Center for Health	Baltimore	Maryland
United States	The Kirklin Clinic of UAB Hospital	Birmingham	Alabama
United States	Northwest Clinical Trials	Boise	Idaho
United States	Radiant Research	Cincinnati	Ohio
United States	J&S Clinical Studies	College Station	Texas
United States	Radiant Research	Columbus	Ohio
United States	Ashton Podiatry Associates, PA	Dallas	Texas
United States	Forest Hills Dermatology Group	Forest Hills	New York
United States	Radiant Research	Greer	South Carolina
United States	The Skin Wellness Center	Knoxville	Tennessee
United States	The Education And Research Foundation, Inc.	Lynchburg	Virginia
United States	International Dermatology Research	Miami	Florida
United States	Associated Skin Care Specialist Minnesota Clinical Study Center	Minneapolis	Minnesota
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	Gateway Health Center	Newburgh	Indiana
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Dermatology Specialists, Inc	Oceanside	California
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Paddington Testing Company	Philadelphia	Pennsylvania
United States	Radiant Research	Pinellas Park	Florida
United States	Oregon Dermatology & Research Center	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	Skin Search of Rochester	Rochester	New York
United States	Endeavor Clinical Trials	San Antonio	Texas
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	Radiant Research	Tucson	Arizona
United States	Martin Foot and Ankle	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Viamet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	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; >0% to =10% nail involvement; >10% to <25% nail involvement; =25% to =50% nail involvement; >50% to =75% nail involvement; >75% nail involvement	48 weeks
Primary	Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities		9 months