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

Last updated: September 15, 2025
Sponsor: Vanda Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Toenail Fungus (Onychomycosis)

Treatment

Trichostatin A

Clinical Study ID

NCT07065773
VP-VTR-297-2201
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 greattoenail.

  • Positive microscopic examination with KOH for dermatophyte hyphae.

  • Positive dermatophyte culture or mixed dermatophyte/Candida culture.

Exclusion

Exclusion Criteria:

  • Presence of other toenail infection.

  • Any disease or condition that may interfere with the evaluation including otherconditions that affect the toenails or significant active tinea pedis.

  • History of other significant chronic fungal disease, psoriasis, lichen planus or useof drug medications for those indications 6 months prior to screening and during thestudy.

  • Participation in a previous clinical trial 3 months prior to screening orparticipation in a research study concurrent with this study.

  • Current or planned pregnancy during the trial period.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Trichostatin A
Phase: 2
Study Start date:
May 05, 2025
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Vanda Investigational Site

    Fremont, California 94538
    United States

    Site Not Available

  • Vanda Investigational Site

    Fremont 5350734, California 5332921 94538
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Denver 5419384, Colorado 5417618 80210
    United States

    Active - Recruiting

  • Vanda Investigational Site

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Vanda Investigational Site

    New Brighton 5039080, Minnesota 5037779 55112
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Austin, Texas 78759
    United States

    Site Not Available

  • Vanda Investigational Site

    Pflugerville 4718711, Texas 4736286 78660
    United States

    Active - Recruiting

  • Vanda Investigational Site

    Forest 4759556, Virginia 6254928 24551
    United States

    Active - Recruiting

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