VADUZ, Liechtenstein, 19 July 2022 – To comply with the new European Medical Device Regulation, bonyf has officially initiated a second clinical safety and efficacy evaluation study of its mouth ulcer cream, AphtoFix®. AphtoFix® is a film-forming cream used for the local treatment of Recurrent Aphtous Stomatitis, more commonly referred to as mouth ulcers. The product forms a thin protective layer on the surfaces of the ulcer that stimulates the natural healing process and quickly reduces pain and burning sensations. The first clinical study undertaken on the product has already proven the safety and efficacy of AphtoFix® (Ref: Sakly et al (BMC Oral Health, 16:17, 2016; The safety and efficacy of AphtoFix® mouth ulcer cream in the management of recurrent aphthous stomatitis)).
In the new study, 2 groups of 20 patients will be enrolled. The first group will be instructed to use a placebo twice a day for 10 days, whilst the second group will use AphtoFix®. Examination of the clinical parameters will be performed after days 1, 3, 7 and 15. Clinical parameters include ulcer size, number of ulcers, healing rate and pain intensity.
The clinical trial will be performed at the Instituto Stomatologico Toscano, Camaiore, Italy, under the supervision of Dr. Simone Marconcini. Results of the clinical study are expected early 2023 and results published in a peer reviewed journal.
The new clinical trial is an important step for bonyf which will further enhance sales of this product and to assure bonyf’s current and new clients of the products’ commercial success on the market. With this new trial, bonyf finalizes its compliance with the new European Medical Device Regulation. AphtoFix® is patented in Europe and is available under bonyf’s own brand and also private label branding.
For more information on the product please follow this link: https://bonyf.com/product/aphtofix/