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Clinical Trials in the USA / NCT07065773
Active, not recruiting Phase 2

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

NCT07065773 · tracked via the Priya Life Science USA tracker
Sponsor
Vanda Pharmaceuticals
Phase
Phase 2
Started
2025-05-05
Last updated
2026-02-04

Condition(s) studied

Onychomycosis of Toenail

Investigational drug(s) / intervention(s)

Trichostatin A →

Trichostatin A: Topical Study Drug

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (5)

FacilityCityRegionStatus
Vanda Investigational Site Fremont California
Vanda Investigational Site Denver Colorado
Vanda Investigational Site New Brighton Minnesota
Vanda Investigational Site Pflugerville Texas
Vanda Investigational Site Forest Virginia

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ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection Enrolling by invitation
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies Recruiting
Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension Recruiting

Other trials for the same condition

Safety and Efficacy of Next Science Gel on Toenail Fungus Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07065773 on ClinicalTrials.gov ↗ ← All trials in the USA