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

Early Visible Improvements during K101-03 Treatment: An Open-Label Multicenter Clinical Investigation in Patients with Onychomycosis and/or Nail Psoriasis

“…As with previous studies of propylene glycol-urea-lactic acid preparations [19,20] , K101-03 produced rapid improvements in the patients included in the present study. After 8 weeks of treatment, 92.2% of patients reported improvement in their target nail.…”

“…Like K101 [19] and Kerasal Nail [20] , K101-03 rapidly improved the physical attributes of onychomycosisaffected nails, with discoloration in particular showing early improvements in the majority of patients.…”

“…There were no treatment-related AEs in the present study. The only treatment-related AEs in previous studies of short-term K101 and Kerasal Nail treatment were 2 cases of administration site pain in patients treated with Kerasal Nail [19,20] . K101, K101-03, and Kerasal Nail are each supplied in a plastic tube with a silicone tip designed to facilitate precise application to affected nails and to minimize potential irritant effects due to excessive skin contact.…”

“…These results confirm previous findings for K101 and Kerasal Nail. In an 8-week study of K101 in 75 onychomycosis patients, 77% of patients reported at least some improvement in an affected nail at 2 weeks and 88% at 4 weeks [19] . A more recent study of Kerasal Nail in onychomycosis showed improvements in 65% of patients after Percentage values are correct to 1 decimal place.…”

“…In a separate study, nail psoriasis patients treated for 16 weeks with a lotion containing propylene glycol and urea showed significant improvements in nail pitting, subungual keratosis, and onycholysis [18] . Other more recent clinical investigations showed rapid improvements in nail appearance and few treatment-related adverse events (AEs) in onychomycosis patients treated with K101 [19] or Kerasal Nail TM (K101-05) [20] . As outlined above, treatments containing propylene glycol, urea, and lactic acid have shown good efficacy and tolerability in clinical investigations.…”