Trial · NCT02267356

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

NCT02267356, Phase 2, Completed, Viamet; results first posted 2020-11-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail. Trials, record NCT02267356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02267356

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
NCT number: NCT02267356
Status: Completed
Phases: Phase 2
Enrollment: 259 participants, actual
Lead sponsor: Viamet
Conditions: Onychomycosis
Interventions: VT-1161, Placebo
First posted: 2014-10-17
Last updated: 2020-11-04
Results first posted: 2020-11-04

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	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 involvement
Primary	Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	9 months

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	48 weeks	Initial 60-week study data. Study extension data not applicable.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	9 months		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	Low Dose 12-week	17	Participants
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	Low Dose 24-week	19	Participants
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	High Dose 12-week	22	Participants
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	High Dose 24-week	18	Participants
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48	Placebo	0	Participants
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	Low Dose 12-week	8	Participants
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	Low Dose 24-week	5	Participants
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	High Dose 12-week	7	Participants
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	High Dose 24-week	9	Participants
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities	Placebo	6	Participants

Source ClinicalTrials.gov

Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Initial Study	STARTED	Low Dose 12-week	53
Initial Study	STARTED	Low Dose 24-week	53
Initial Study	STARTED	High Dose 12-week	52
Initial Study	STARTED	High Dose 24-week	54
Initial Study	STARTED	Placebo	47
Initial Study	COMPLETED	Low Dose 12-week	47
Initial Study	COMPLETED	Low Dose 24-week	48
Initial Study	COMPLETED	High Dose 12-week	42
Initial Study	COMPLETED	High Dose 24-week	43
Initial Study	COMPLETED	Placebo	42

1 to 10 of 30Source ClinicalTrials.gov

See all 30 participant flow

Adverse events1,045

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Tachycardia	Cardiac disorders	Low Dose 12-week	0	53
other	Tachycardia	Cardiac disorders	Low Dose 24-week	0	53
other	Tachycardia	Cardiac disorders	High Dose 12-week	0	52
other	Tachycardia	Cardiac disorders	High Dose 24-week	0	54
other	Tachycardia	Cardiac disorders	Placebo	1	47
other	Ventricular extrasystoles	Cardiac disorders	Low Dose 12-week	0	53
other	Ventricular extrasystoles	Cardiac disorders	Low Dose 24-week	1	53
other	Ventricular extrasystoles	Cardiac disorders	High Dose 12-week	0	52
other	Ventricular extrasystoles	Cardiac disorders	High Dose 24-week	0	54
other	Ventricular extrasystoles	Cardiac disorders	Placebo	0	47

1 to 10 of 1,045Source ClinicalTrials.gov

See all 1,045 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Dose 12-week
Total, all-cause mortality	Low Dose 24-week
Total, all-cause mortality	High Dose 12-week
Total, all-cause mortality	High Dose 24-week
Total, all-cause mortality	Placebo
Total, other adverse events	Low Dose 12-week	29	53
Total, other adverse events	Low Dose 24-week	26	53
Total, other adverse events	High Dose 12-week	31	52
Total, other adverse events	High Dose 24-week	36	54
Total, other adverse events	Placebo	26	47

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32421854	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02267356

GET https://conductscience.org/api/trials/v1/NCT02267356/flow?page=2

API reference For AI assistants