Early and Visible Improvements after Application of K101 in the Appearance of Nails Discoloured and Deformed by Onychomycosis

Abstract

Onychomycosis is a fungal infection of the nails of the fingers and toes and is difficult to cure. A previous 24-week, placebo-controlled study demonstrated that a solution containing propylene glycol, urea and lactic acid (K101) was well-tolerated and effective in the treatment of onychomycosis. Patients who received K101 judged that their condition had improved from Week 2 of treatment onwards. The aim of the current study was to further evaluate and document early visible effects on nail appearance after application of topical K101 in an 8-week baseline-controlled study in 75 patients. Patients graded the appearance of their nail compared with baseline using a four-point scale. Compared with baseline, 91.8% (67/73; 95% confidence interval (CI): 83.0%, 96.9%) of the patients experienced at least some improvement in their target nail after 8 weeks of treatment. At Week 2, the proportion showing some improvement was 76.7% (56/73; 95% CI: 65.4%, 85.8%) with this number increasing to 87.7% (64/73; 95% CI: 77.9%, 94.2%) at Week 4. Proportions of patients reporting less thickened, less discoloured, less brittle and softer nails increased over the course of the study. No safety issues were identified. In conclusion, K101 provided early visible improvements in nails affected by onychomycosis.