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.

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

Alternative treatments for seborrhoeic dermatitis are needed because of the increasing risk of anti-fungal resistance to existing therapies. To investigate the efficacy, safety and tolerability of topical scalp treatment with K301 solution. Two multi-centre, randomised, double-blind studies were conducted. Study I: 4 weeks of once-daily treatment with either one form of K301 (a or b) or placebo, followed by 4 weeks of maintenance treatment three times-per-week. Study II: 4 weeks of K301 (a) or placebo once-daily. Study I: 98 patients enrolled (K301a + b, n = 51; placebo, n = 47) and 83 completed; 201 entered Study II (K301a, n = 136; placebo, n = 65) and 195 completed. Erythema and desquamation sum score at 4 weeks, mean (SD) values were 2.4 (2.0) for K301a + b and 3.2 (2.2) for placebo in Study I (P = 0.025) and 2.5 (1.9) for K301a and 3.2 (1.8) for placebo in Study II (not significant). In both studies, 4-week desquamation scores were significantly improved for K301 vs. placebo (P < 0.05). Both studies showed significant improvements in symptomatic investigator and patient assessments for K301 over placebo after 4 weeks (P < 0.05). Treatment-related adverse events were generally mild and included some smarting or burning upon application. The K301 was well tolerated and associated with clinically meaningful improvements in seborrhoeic dermatitis endpoints.

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Summary K101 Nail Solution (trademarks Emtrixâ, Nalox TM , Naloc TM ) is a combination of propylene glycol, urea and lactic acid in a topical formulation for the treatment of nails affected by onychomycosis. The aim of this study was to investigate the Minimal Cidal Concentration (MCC) of K101 Nail Solution against Trichophyton rubrum and Candida albicans as well as the effect of K101 Nail Solution on the micromorphology of these fungi. The MCC of K101 Nail Solution against T. rubrum and C. albicans was 50% after 60-min exposure time. A MCC of 50% for K101 Nail Solution means that K101 Nail Solution diluted with e.g. water to 50% will totally kill the fungi tested. In the scanning electron microscope C. albicans cells, treated with 50% K101 Nail Solution, showed a shrunken surface. T. rubrum cells were severely damaged shown as collapse and degradation of the cells. In the transmission electron microscope most C. albicans cells, treated with 50% K101 Nail Solution exhibited destroyed organelles and many necrotic cells were found. The cell wall was clearly degraded and the contact between the cell wall and the inner membrane was punctured. In T. rubrum most cells were necrotic. Some cells were clearly collapsed and the content in the cytoplasm was degraded shown as small membrane vesicles and many big vacuoles. The cell wall was clearly degraded and the membrane was punctured. In conclusion, this in vitro study documents the efficacy of K101 Nail Solution against T. rubrum and C. albicans.