OnychomycosisPhase 2NCT02267356
A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Onychomycosis of the Toenail
A Phase 2 study testing VT-1161 in people with Onychomycosis, run by Viamet at 33 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Onychomycosis
- What is being tested?
- VT-1161
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 259 participants
- Where
- 33 sitesUnited States
- Study dates
- 17 Feb 2015to 7 Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Radiant Research
Akron, Ohio, 44311
Academic Dermatology Associates
Albuquerque, New Mexico, 87106
DermResearch
Austin, Texas, 78759
Mid Atlantic Research Center for Health
Baltimore, Maryland, 21214
The Kirklin Clinic of UAB Hospital
Birmingham, Alabama, 35233
Northwest Clinical Trials
Boise, Idaho, 83704
Radiant Research
Cincinnati, Ohio, 45249
J&S Clinical Studies
College Station, Texas, 77845
Radiant Research
Columbus, Ohio, 43212
Ashton Podiatry Associates, PA
Dallas, Texas, 75243
Forest Hills Dermatology Group
Forest Hills, New York, 11395
Radiant Research
Greer, South Carolina, 29621
The Skin Wellness Center
Knoxville, Tennessee, 37922
The Education And Research Foundation, Inc.
Lynchburg, Virginia, 24501
International Dermatology Research
Miami, Florida, 33144
Associated Skin Care Specialist Minnesota Clinical Study Center
Minneapolis, Minnesota, 55432
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Gateway Health Center
Newburgh, Indiana, 47630
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Dermatology Specialists, Inc
Oceanside, California, 92056
Skin Specialists, PC
Omaha, Nebraska, 68144
Paddington Testing Company
Philadelphia, Pennsylvania, 19103
Radiant Research
Pinellas Park, Florida, 33781
Oregon Dermatology & Research Center
Portland, Oregon, 97210
Oregon Medical Research Center
Portland, Oregon, 97223
Skin Search of Rochester
Rochester, New York, 14623
Endeavor Clinical Trials
San Antonio, Texas, 78229
Therapeutics Clinical Research
San Diego, California, 92123
Center For Clinical Research
San Francisco, California, 94115
Radiant Research
Santa Rosa, California, 95405
Radiant Research
Tucson, Arizona, 85712
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
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
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.
- Conditions
- Onychomycosis
- Being tested
- VT-1161, Placebo
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-1161Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose 12-week | Experimental | 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 Receives: Drug: VT-1161 |
| Low dose 24-week | Experimental | 2 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks Receives: Drug: VT-1161 |
| High dose 12-week | Experimental | 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 Receives: Drug: VT-1161 |
| High dose 24-week | Experimental | 4 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks Receives: Drug: VT-1161 |
| Placebo | Placebo comparator | 4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 weeks
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study start17 Feb 2015
- Primary completion18 Oct 2016
- Study completion7 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OnychomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viamet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267356
- Sponsor's protocol ID
- VMT-VT-1161-CL-005
- Status last verified
- Oct 2020
- First submitted
- 8 Oct 2014
- Last updated
- 4 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32421854
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02267356
- Acronym / sponsor ID
- VMT-VT-1161-CL-005
- Conditions
- Onychomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- ViametIndustry (pharma, biotech, devices)
- Study start
- 17 Feb 2015 (actual)
- Primary completion
- 18 Oct 2016 (actual)
- Study completion
- 7 Jul 2017 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Posted 4 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low dose 12-week | Experimental | Drug: VT-11612 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 |
| Low dose 24-week | Experimental | Drug: VT-11612 VT-1161 150mg tablets and 2 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
| High dose 12-week | Experimental | Drug: VT-11614 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 | Experimental | Drug: VT-11614 VT-1161 150mg tablets once daily for 2 weeks, then once weekly for 22 weeks |
| Placebo | Placebo comparator | Drug: Placebo4 placebo tablets once daily for 2 weeks, then once weekly for 22 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-1161 | Drug | High dose 12-week, High dose 24-week, Low dose 12-week, Low dose 24-week |
| Placebo | Drug | Placebo |
Primary outcome
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48
Time frame: 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
Study Extension - Number of Subjects Who Experienced Treatment-emergent Adverse Events and Lab Abnormalities
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32421854Elewski 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.
Related trials for Onychomycosis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
Not yet recruiting
Systemic Antifungal Plus Q-Switched Nd:YAG Laser for Onychomycosis
Onychomycosis
Active, not recruitingPhase 1
Photodynamic Therapy For Onychomycosis
Onychomycosis of Toenail
Recruiting
URGO MICKAEL Filmogel, Topical Treatment of Onychomycosis
Onychomycosis of Toenail
Active, not recruiting
Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis
Onychomycosis of Toenails, Onychomycosis of Fingernail
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VT-1161 in people with Onychomycosis, run by Viamet at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Subjects in the Intent-to-treat Population With Complete Cure, Defined as Clinical AND Mycological Cure, at Week 48 (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.