An Open Label Study to Investigate the Safety and Tolerability of Trichostatin A in Patients With Mild to Severe Onychomycosis
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Vanda Investigational Site
RECRUITING
Fremont
Colorado
Vanda Investigational Site
RECRUITING
Denver
Minnesota
Vanda Investigational Site
RECRUITING
New Brighton
Texas
Vanda Investigational Site
RECRUITING
Pflugerville
Virginia
Vanda Investigational Site
RECRUITING
Forest
Contact Information
Primary
Vanda Pharmaceuticals
clinicaltrials@vandapharma.com
202-734-3400
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2026-05
Participants
Target number of participants: 50
Treatments
Experimental: Trichostatin A
Related Therapeutic Areas
Sponsors
Leads: Vanda Pharmaceuticals