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 - 17/08/22
, J. Brennan b, J. Barrett b, J. Makarus c, S. Callanan c, E. Spillane d, T. Patton bHighlights |
• | 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. |
Abstract |
Background |
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.
Design |
A randomized, single-blinded, controlled parallel group study with allocation concealment was carried out.
Methods |
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.
Results |
Statically significant differences for % change in area of clear visible toenail (p<0.05) of 39.8, 40.0 and 70.7 in favour of Mycosinate® were noted at time points 6 weeks, 12 weeks, and 6 months respectively when compared to Amorolfine. No statistically significant differences were noted for mycological cure rates. No adverse events, serious adverse events or deaths occurred for either treatment.
Conclusion |
Mycosinate® is a promising novel topical onychomycosis treatment with high rates of efficacy and excellent safety profile. Further clinical trials are warranted.
(EU Clinical Trials Register 2018/000294/78)
El texto completo de este artículo está disponible en PDF.Key words : Onychomycosis, Reactive oxygen, Mycosinate®, Fungal nail infection
Esquema
| Funding Sources: This work was supported by Enterprise Ireland HPSU Funding (Project ID Number is 161924); Nektr Technologies Ltd. provided the Mycosinate® product. |
|
| Conflict of Interest: M. Ehrensberger is a Project Manager at Nektr Technologies Ltd., C.W.C. Boal is the Chief Project Manager at Nektr Technologies Ltd., J. Brennan, J. Barrett and T. Patton are shareholders of Nektr Technologies Ltd. |
Vol 32 - N° 3
Artículo 101256- août 2022 Regresar al número
Artículo precedente
- Antifungal effect of hydroethanolic extract of Fridericia chica (Bonpl.) L. G. Lohmann leaves and its therapeutic use in a vulvovaginal candidosis model
- William Gustavo Lima, Marcelo Gonzaga Freitas Araújo, Júlio César Moreira Brito, Rachel Oliveira Castilho, Valbert Nascimento Cardoso, Simone Odília Antunes Fernandes
- A novel method for predicting the efficacy of topical drugs on onychomycosis: A comparison of efinaconazole and luliconazole
- Akane Masumoto, Masashi Takagi, Keita Sugiura, Yoshiki Matsuda, Saki Nakamura, Yoshiyuki Tatsumi
Bienvenido a EM-consulte, la referencia de los profesionales de la salud.
El acceso al texto completo de este artículo requiere una suscripción.
¿Ya suscrito a @@106933@@ revista ?