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

Vanda Pharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: Onychomycosis of Toenail

Treatments: Drug: Trichostatin A

Study type: Interventional

Funder types: Industry

Identifiers

NCT07065773

VP-VTR-297-2201

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Trichostatin A

Experimental group

Treatment:

Drug: Trichostatin A