ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-05
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT07065773

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willingness to provide signed and dated written voluntary informed consent.
  2. * Adults with diagnosis of mild-to-severe DLSO/DSO affecting at least one great toenail.
  3. * Positive microscopic examination with KOH for dermatophyte hyphae.
  4. * Positive dermatophyte culture or mixed dermatophyte/Candida culture.
  1. * Presence of other toenail infection.
  2. * Any disease or condition that may interfere with the evaluation including other conditions that affect the toenails or significant active tinea pedis.
  3. * 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.
  4. * Participation in a previous clinical trial 3 months prior to screening or participation in a research study concurrent with this study.
  5. * Current or planned pregnancy during the trial period.

Contacts and Locations

Study Locations (Sites)

Vanda Investigational Site
Fremont, California, 94538
United States
Vanda Investigational Site
Denver, Colorado, 80210
United States
Vanda Investigational Site
New Brighton, Minnesota, 55112
United States
Vanda Investigational Site
Pflugerville, Texas, 78660
United States
Vanda Investigational Site
Forest, Virginia, 24551
United States

Collaborators and Investigators

Sponsor: Vanda Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05
Study Completion Date2026-09

Study Record Updates

Study Start Date2025-05-05
Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

  • Onychomycosis
  • Onychomycosis of Toenail
  • Trichophyton rubrum
  • Trichophyton mentagrophytes

Additional Relevant MeSH Terms

  • Onychomycosis of Toenail