Treatment of distal subungual onychomycosis with a topical preparation of urea, propylene glycol and lactic acid: results of a 24‐week, double‐blind, placebo‐controlled study

Abstract

Onychomycosis is difficult to cure as this requires eradication of the primary infection and protection of new areas of growth from reinfection. A new topical treatment (K101) has been developed. The aim of this study was to assess the efficacy, safety and tolerability of K101 treatment of distal subungual onychomycosis. This was a 24-week (plus 2-week washout), multicentre, randomised, double-blind, placebo-controlled study in 493 patients with distal subungual onychomycosis (K101, n = 346; placebo, n = 147), stratified according to degree of nail involvement. More patients with ≤50% nail involvement achieved the primary endpoint (mycological cure after 26 weeks) in the K101 group (27.2%) than placebo (10.4%; P = 0.0012). Proportions for patients with 51-75% involvement were 19.1% for K101 and 7.0% for placebo (not significant). More patients applying K101 than placebo judged that their condition had improved from week 2 (P = 0.0148) to week 24 (P = 0.0004). No safety issues were identified. K101 provides early visible improvements in nail appearance and a clinically meaningful antifungal activity.

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

“…The proportion of patients who were mycologically cured after 24 weeks of treatment (plus a 2-week washout) was higher for K101 than for a placebo preparation (27.2 vs. 10.4%). In addition, more patients receiving K101 judged that their condition had improved, with statistically significant differences versus placebo from 2 weeks until the end of the study at 26 weeks [17] . 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] .…”

A Retrospective Study Comparing K101 Nail Solution as a Monotherapy and in Combination with Oral Terbinafine or Itraconazole for the Treatment of Toenail Onychomycosis

“…Previously, mycological cure after K101 treatment for 6 months was 27.2% (dermatophyte-confirmed onychomycosis with ≤50% of nail involvement), while patient-rated reduction or patient-rated absence of symptoms was reported by 42.9% [12]. The current study included patients with up to 75% of nail involvement; complete and mycological cure of dermatophyte infections after 15 months of K101 solution alone were 33.3 and 48.5%, respectively.…”

The effect of K101 Nail Solution on Trichophyton rubrum and Candida albicans growth and ultrastructure

“…This study clearly documented the efficacy of K101 Nail Solution against these fungi in vitro with very good MCC values. Other studies have shown the clinical efficacy of K101 Nail Solution in the treatment of nails affected by onychomycosis …”

“…K101 Nail Solution is a mixture of propylene glycol, lactic acid and urea. The pH is approximately 4 which may contribute to its efficacy, compared with other topical agents . It is well known that a low pH in skin and nails is important for the antimicrobial protection against both pathogenic fungi and bacteria .…”

“…The concept of using propylene glycol solutions of urea and lactic acid to treat onychomycosis has been confirmed in a placebo‐controlled study that documented the efficacy and tolerability of K101 Nail Solution vs. placebo in 493 patients with onychomycosis. A greater number of patients who received K101 Nail Solution experienced mycological cure after 26 weeks of treatment (27% vs. 10%) . Also, almost half the patients who received K101 Nail Solution considered that their condition had shown at least some improvement from week 2, and approximately 75% from week 8 of treatment onwards.…”