Safety, Tolerability and Efficacy of Trichostatin A in Patients With Mild to Severe Onychomycosis

An Open Label Study to Investigate the Safety and Tolerability of Trichostatin A in Patients With Mild to Severe Onychomycosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07065773

Enrollment

Registered

2025-07-15

Start date

2025-05-05

Completion date

2026-09-01

Last updated

2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Onychomycosis of Toenail

Keywords

Onychomycosis, Onychomycosis of Toenail, Trichophyton rubrum, Trichophyton mentagrophytes

Brief 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 weeks of treatment with VTR-297.

Interventions

DRUGTrichostatin A

Topical Study Drug

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026