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

NCT07065773 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: VP-VTR-297-2201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

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.

Conditions

Onychomycosis of Toenail

Keywords

Onychomycosis; Onychomycosis of Toenail; Trichophyton rubrum; Trichophyton mentagrophytes

Outcome Measures

Primary Outcomes (1)

• 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.

  24 weeks

Study Arms (1)

Trichostatin A

EXPERIMENTAL

Drug: Trichostatin A

Interventions

Trichostatin A DRUG

Topical Study Drug

Trichostatin A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Vanda Pharmaceuticals: lead

Study Sites (5)

Vanda Investigational Site

Fremont, California, 94538, United States

Location

Vanda Investigational Site

Denver, Colorado, 80210, United States

Location

Vanda Investigational Site

New Brighton, Minnesota, 55112, United States

Location

Vanda Investigational Site

Pflugerville, Texas, 78660, United States

Location

Vanda Investigational Site

Forest, Virginia, 24551, United States

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

trichostatin A

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: July 15, 2025
• Study Start: May 5, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)