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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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