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NCT Number: NCT07065773

Safety, Tolerability and Efficacy 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Onychomycosis of Toenail Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Onychomycosis Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigational Site, Fremont, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trichostatin A

Drug

Topical Study Drug

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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