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

Running, not enrolling · Phase 2

Conditions studied: Onychomycosis of Toenail

In brief

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.

Key facts

Study ID

NCT07065773

Run by

Vanda Pharmaceuticals

People needed

50

Starts

2025-05-05

Expected to finish

2026-09-01

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Vanda Investigational Site — Fremont, California, United States
• Vanda Investigational Site — Denver, Colorado, United States
• Vanda Investigational Site — New Brighton, Minnesota, United States
• Vanda Investigational Site — Pflugerville, Texas, United States
• Vanda Investigational Site — Forest, Virginia, United States

Full record on ClinicalTrials.gov

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