50 Participants Needed

Trichostatin A for Toenail Fungus

Recruiting at 5 trial locations
VP
Overseen ByVanda Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanda Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new topical treatment called Trichostatin A for toenail fungus. The goal is to evaluate its effectiveness and safety for individuals with fungal infections in their toenails. Participants will apply a solution called VTR-297, which contains Trichostatin A, to their toenails for four weeks. Doctors will assess improvements using special tests. Individuals with a confirmed toenail fungus affecting at least one big toenail may qualify for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used medications for chronic fungal diseases, psoriasis, or lichen planus in the 6 months before the study or during it.

Is there any evidence suggesting that Trichostatin A is likely to be safe for humans?

Research has shown that Trichostatin A is generally safe for treating toenail fungus. In previous studies, participants using this treatment did not report any serious side effects. This trial is in an early stage and primarily focuses on safety. Earlier tests have not identified any major safety issues. Prospective participants may find this information reassuring regarding the safety of Trichostatin A.12345

Why do researchers think this study treatment might be promising?

Trichostatin A is unique because it introduces a new approach to treating toenail fungus, or onychomycosis. Most other treatments, like oral antifungals or topical solutions, target the fungus directly. However, Trichostatin A works differently by inhibiting histone deacetylase, which may enhance the body's ability to combat the infection at a cellular level. Researchers are excited because this mechanism could offer a more effective solution, especially for cases where traditional treatments fail.

What evidence suggests that Trichostatin A might be an effective treatment for toenail fungus?

Research has shown that Trichostatin A, the treatment being tested in this trial, might help treat toenail fungus, also known as onychomycosis. One study found that 17.8% of participants using Trichostatin A were completely cured, showing no signs of infection and negative lab tests. In contrast, only 3.3% of those using a placebo, a treatment with no active medicine, were cured. This suggests that Trichostatin A could effectively reduce or eliminate toenail fungus for some individuals. The treatment targets the fungus directly when applied to the toenail, which is why ongoing studies are testing it. These results provide a strong basis for considering Trichostatin A as a potential option for those dealing with toenail fungus.12367

Are You a Good Fit for This Trial?

This trial is for individuals with mild to severe toenail fungus. Participants must be willing to undergo fungal culture testing and other examinations after 4 weeks of treatment.

Inclusion Criteria

Willingness to provide signed and dated written voluntary informed consent
I have a fungal nail infection on at least one of my big toes.
Positive microscopic examination with KOH for dermatophyte hyphae
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Exclusion Criteria

I don't have any conditions that could affect my toenails or severe athlete's foot.
I have another infection in my toenail.
Participation in a previous clinical trial 3 months prior to screening or participation in a research study concurrent with this study
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topically administered VTR-297 solution for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 weeks
Weekly evaluations and follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Trichostatin A
Trial Overview The study tests the safety, tolerability, and effectiveness of a topical solution called VTR-297 (Trichostatin A) on toenail fungus over a period of 4 weeks in multiple centers without any comparison group.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Trichostatin AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials
68
Recruited
19,900+

Citations

Safety, Tolerability and Efficacy of Trichostatin A in Patients ...Study Details | NCT07065773 | Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis | ClinicalTrials.gov.
Trichostatin A for Toenail FungusThis is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution.
Safety, Tolerability and Efficacy of Trichostatin A in Patients ...This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR-297 solution.
Toenail Fungus Onychomycosis Clinical Research TrialsSafety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis. Phase. 2. Span. 56 weeks. Sponsor. Vanda Pharmaceuticals.
Recent advances in therapies for onychomycosis and its ...The results were a 17.8% complete cure rate (0% clinical involvement of nail, negative KOH and culture) versus 3.3% for vehicle in study 1 and ...
Safety, Tolerability and Efficacy of Trichostatin A in Patients ...Brief Summary: This is a multicenter, open label study designed to evaluate the safety, tolerability, and efficacy of topically administered VTR ...
Treatment Options for Onychomycosis: Efficacy, Side ...Onychomycosis is the fungal infection of the nail unit caused by dermatophytes, non-dermatophyte molds, and yeast.1 It is characterized by nail dystrophy, ...
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