Onychomycosis of ToenailPhase 2NCT07065773
Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis
A Phase 2 study testing Trichostatin A in people with Onychomycosis of Toenail, run by Vanda Pharmaceuticals at 5 sites in United States.
Trial summary
This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution. The efficacy objectives of the study will be assessed using fungal culture testing, Neutral Red Staining (NRS) microscopy examination, and KOH microscopy examination after 4… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Onychomycosis of Toenail
- What is being tested?
- Trichostatin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 5 May 2025to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willingness to provide signed and dated written voluntary informed consent.
- Adults with diagnosis of mild-to-severe DLSO/DSO affecting at least one great toenail.
- Positive microscopic examination with KOH for dermatophyte hyphae.
- Positive dermatophyte culture or mixed dermatophyte/Candida culture.
Who cannot join
- Presence of other toenail infection.
- Any disease or condition that may interfere with the evaluation including other conditions that affect the toenails or significant active tinea pedis.
- History of other significant chronic fungal disease, psoriasis, lichen planus or use of drug medications for those indications 6 months prior to screening and during the study.
- Participation in a previous clinical trial 3 months prior to screening or participation in a research study concurrent with this study.
- Current or planned pregnancy during the trial period.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Vanda Investigational Site
Denver, Colorado, 80210
Vanda Investigational Site
Forest, Virginia, 24551
Vanda Investigational Site
Fremont, California, 94538
Vanda Investigational Site
New Brighton, Minnesota, 55112
Vanda Investigational Site
Pflugerville, Texas, 78660
About this study
Official title: An Open Label Study to Investigate the Safety and Tolerability of Trichostatin A in Patients With Mild to Severe Onychomycosis
This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution. The efficacy objectives of the study will be assessed using fungal culture testing, Neutral Red Staining (NRS) microscopy examination, and KOH microscopy examination after 4 weeks of treatment with VTR-297.
- Conditions
- Onychomycosis of Toenail
- Being tested
- Trichostatin A
- Keywords
- Onychomycosis, Onychomycosis of Toenail, Trichophyton rubrum, Trichophyton mentagrophytes
- Medical subject headings
- Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichostatin ADrug
Topical Study Drug
| Study group | Role | What they receive |
|---|---|---|
| Trichostatin A | Experimental | Not described Receives: Drug: Trichostatin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Subjects will be asked about AEs weekly during the evaluation phase and at every follow-up visit; descriptions of AEs will include, at a minimum: date of onset, date ended, severity, seriousness, relationship to the study drug, and outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start5 May 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Onychomycosis of ToenailStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065773
- Sponsor's protocol ID
- VP-VTR-297-2201
- Status last verified
- Feb 2026
- First submitted
- 5 Jun 2025
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Investigate the Safety and Tolerability of Trichostatin A in Patients With Mild to Severe Onychomycosis
- ClinicalTrials.gov ID
- NCT07065773
- Acronym / sponsor ID
- VP-VTR-297-2201
- Conditions
- Onychomycosis of Toenail
- Keywords
- Onychomycosis, Onychomycosis of Toenail, Trichophyton rubrum, Trichophyton mentagrophytes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution. The efficacy objectives of the study will be assessed using fungal culture testing, Neutral Red Staining (NRS) microscopy examination, and KOH microscopy examination after 4 weeks of treatment with VTR-297.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trichostatin A | Experimental | Drug: Trichostatin A |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willingness to provide signed and dated written voluntary informed consent.
- Adults with diagnosis of mild-to-severe DLSO/DSO affecting at least one great toenail.
- Positive microscopic examination with KOH for dermatophyte hyphae.
- Positive dermatophyte culture or mixed dermatophyte/Candida culture.
Key exclusion criteria (5 listed)
- Presence of other toenail infection.
- Any disease or condition that may interfere with the evaluation including other conditions that affect the toenails or significant active tinea pedis.
- History of other significant chronic fungal disease, psoriasis, lichen planus or use of drug medications for those indications 6 months prior to screening and during the study.
- Participation in a previous clinical trial 3 months prior to screening or participation in a research study concurrent with this study.
- Current or planned pregnancy during the trial period.
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 |
|---|---|---|
| Trichostatin ATopical Study Drug | Drug | Trichostatin A |
Primary outcome
Safety and Tolerability
Time frame: 24 weeks
Subjects will be asked about AEs weekly during the evaluation phase and at every follow-up visit; descriptions of AEs will include, at a minimum: date of onset, date ended, severity, seriousness, relationship to the study drug, and outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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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.
5 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 Trichostatin A in people with Onychomycosis of Toenail, run by Vanda Pharmaceuticals at 5 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Safety and Tolerability (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.