A Clinical Investigation to Evaluate the Safety and Performance of a Novel Self-Administered Treatment Kit for Ingrowing Toenail

Abstract

Background: Ingrown toenail often results in a painful cycle of infection and inflammation and can affect the ability to go about everyday activities. In the UK and Europe, there are limited ways to prevent the development of ingrowing toenail without specialist intervention. Treatments are often invasive and may require periods of time off work. This prospective, single-site, non-comparative clinical study evaluates the performance, safety and convenience of a treatment kit that can be applied at home at the earliest signs of ingrowing toenail. Methods: Patients (n = 36) with mild ingrowing toenail used the Scholl Ingrowing Toenail Treatment kit for 6 weeks, with assessments by study investigators at Days 0, 21 and 42. The kit comprised a set of toenail clips and a spray, correct use of which was monitored at site visits and through patient diaries. Results: All patients enrolled in the study completed the 42-day treatment period. Severity of ingrowing toenail was significantly reduced in 88.9% (95% CI: 78.62, 99.15) of patients at the end of the study. Twenty-two patients (61.1%) exhibited full resolution of ingrowing toenail at Day 42 and none showed an increase in severity. Reduction in pain and severity of ingrowing toenail from baseline was significant at Days 21 and 42 (p < 0.0001). 63.9% of patients reported reduced discomfort and trauma using the treatment kit on the first day of treatment, which increased to 97.2% at the following visits. No serious adverse events or device events were reported. Most patients reported that the clips were convenient to use and did not impede their daily activities. Conclusions: The ingrowing toenail treatment kit was convenient and easy for patients to use at home and resulted in reduced pain and severity of ingrowing toenail at early stages of the condition.