A clinical study for the treatment of onychomycosis patients using a novel ROS producing onychomycosis treatment when compared against 5% amorolfine topical lacquer to reduce the visible size of infected toenails

• Published in: Journal de mycologie médicale 2022-08, Vol.32 (3), p.101256-101256, Article 101256
• Main Authors: Ehrensberger, M., Boal, C.W.C., Brennan, J., Barrett, J., Makarus, J., Callanan, S., Spillane, E., Patton, T.
• Format: Article
• Language: English
• Subjects: Fungal nail infection; Mycosinate; Onychomycosis; Reactive oxygen
• ISSN: 1156-5233; 1773-0449
• DOI: 10.1016/j.mycmed.2022.101256

•The novel antimicrobial compound Mycosinate® outperformed the established product Amorolfine in the treatment of onychomycosis.•Mycosinate® is based on a sustained hydrogen peroxide release system.•Due to the well-known antimicrobial effects, the low molecular weight and hydrophilic nature of Mycosinate's® therapeutic payload, the novel formulation can easily penetrate the toenail and eradicate the fungal infection. Onychomycosis affects approximately 5% of the population worldwide without satisfactory treatment options regarding efficacy and safety. The aim of this first in human study was to compare the safety and efficacy of the novel compound Mycosinate® against an approved toenail lacquer containing 5% Amorolfine. A randomized, single-blinded, controlled parallel group study with allocation concealment was carried out. Thirty-eight participants either used the novel compound Mycosinate® or an approved toenail lacquer containing 5% Amorolfine for topical application in their own homes. Outcome measures included a) % change in area of clear visible toenail, b) mycological cure rate and c) safety assessments. Statically significant differences for % change in area of clear visible toenail (p