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

Not Applicable

Recruiting

• Conditions: Onychomycosis of Toenail
• Interventions: Drug: Trichostatin A

• Registration Number: NCT07065773
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-05
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15
• Primary Completion: 2026-03
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trichostatin A	Trichostatin A	-

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Austin, Texas, United States