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.
Eligibility
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.