RECRUITING

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

Description

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
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Related Conditions:

Onychomycosis of Toenail

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Onychomycosis of Toenail
Intervention / Treatment

-

Contacts and Locations

Fremont

Vanda Investigational Site, Fremont, California, United States, 94538

New Brighton

Vanda Investigational Site, New Brighton, Minnesota, United States, 55112

Austin

Vanda Investigational Site, Austin, Texas, United States, 78759

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanda Pharmaceuticals,

Study Record Dates

2026-05