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

Abstract

Introduction: Onychomycosis and nail psoriasis can be embarrassing to patients, so improving the appearance of affected nails should be one of the key short-term goals of treatment. Methods: An 8-week open-label multicenter study was conducted to assess whether K101-03, a marketed topical treatment containing propylene glycol, glycerol, urea, and lactic acid, could produce rapid cosmetic improvements in affected nails. Adult patients with a big toenail or thumbnail (the “target” nail) affected by onychomycosis (n = 72) or psoriasis (n = 34) or both (n = 1) applied K101-03 to their affected nails once a day for 8 weeks. During and after treatment, patients rated the overall appearance of their target nail on a 4-point scale. They also assessed whether thickening, discoloration, brittleness, and softness of the target nail had improved since baseline. Adverse events (AEs) that occurred between the first application of K101-03 and the end of treatment were recorded and categorized according to severity and relationship to K101-03. Results: After 8 weeks of K101-03 treatment, 92.2% of patients (95% confidence interval [CI] 87.06-97.40) reported at least some improvement in the target nail. After 1 week of treatment, 78.3% of patients with onychomycosis (95% CI 68.53-87.99) reported at least some improvement in the target nail, and 55.1% of them reported that discoloration of their target nail had improved. Three patients reported a total of 5 AEs, none of which were judged to be related to K101-03. Conclusions: In summary, K101-03 was well tolerated in patients with onychomycosis or nail psoriasis and rapidly improved their nails.

Rapid cosmetic improvements in nail psoriasis patients treated with K101-03

“…In contrast, there have been only three cases with a missense mutation (p.N55T in exon 3 and p.R952C in exon 7) in the TRPS1 gene outside the GATA zinc finger domain [5,6]. These patients had sparse hair, facial abnormalities, and brachydactyly, but neither systemic anomalies nor intellectual disability, similar to our patient.…”

“…K101-03, a marketed product containing propylene glycol, urea, and lactic acid, was recently investigated in an open-label single-arm eight-week post-marketing clinical study conducted at eight sites in Italy. K101-03 was shown to give rapid cosmetic improvements in nails affected by onychomycosis or psoriasis [6]. We herein present a supplementary analysis of the specific efficacy of K101-03 in patients with nail psoriasis.…”

“…We herein present a supplementary analysis of the specific efficacy of K101-03 in patients with nail psoriasis. The parent study [6] was conducted in accordance with the Declaration of Helsinki, ICH E6 Good Clinical Practice, ISO 14155:2011, MEDDEV guidelines, and Italian regulations, and with ethics committee approval for the clinical investigation plan. The nail psoriasis patients included in the present analysis (adults of both sexes) were screened at an initial study visit.…”

“…The p.N55T mutation in exon 3 seems to prevent TRPS1 from fully interacting with Runx2, which is repressed by TRPS1 during chondrocyte differentiation and perichondrial mineralization [3,5]. The p.R952C mutation in exon 7 prevents the transport of TRPS1 into the nucleus, subsequently reducing the nuclear TRPS1 concentration [6]. Both mutations seem to be associated with a mild-to-moderate TRPS I phenotype.…”

Clinical evidences of urea at high concentration on skin and annexes

“…Nail thickening is a common problem of the toenails, especially in elderly people, and it causes considerable cosmetic discomfort, since thickened nails are hard, difficult to trim, and often make wearing shoes painful. Nail thickening may be idiopathic, or secondary to other diseases ranging from onychomycosis to psoriasis, 17,18 onychogryphosis and pincer nails. 19 Urea at high concentrations induces nail softening and permits nail trimming or nail plate removal without irritation of the periungual tissues (Figures 2 and 3 In onychomycosis, the application of 40% urea cream is effective especially when nails are thickened 18 and/or uplifted and the patient complains of pain, spontaneous or when wearing shoes, with difficult walking.…”