A pre-market interventional, single-arm clinical investigation of a new topical lotion based on hyaluronic acid and peptides, EGYFILTM, for the treatment of pain and stiffness in soft tissues

BMC Musculoskeletal Disorders

Research

Luca Forte¹  Jo Serrentino²  Stefano Picotti³ 

[1] Contrad Swiss SA, Via Ferruccio Pelli 2, 6900, Lugano, Switzerland;International Institute of Clinical Ecology (IICE), Quebec, Canada;Poliambulatorio Centro Sistema Salute, Varese, Italy;

关键词: Myofascial tension;    Anti-inflammatory;    Pain;    Peptides;    Hyaluronic acid;    Musculoskeletal;   

DOI  :  10.1186/s12891-023-06903-y

 received in 2023-02-13, accepted in 2023-09-21,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundMuscle pain and stiffness are strictly interconnected. Injuries frequently occur during sport activities, causing muscle pain, with or without stiffness, and require effective as well as fast-acting treatments. Topical products can be ideal for the treatment of such physical alterations as they are convenient and simple to use. In this study, it was investigated the application of a novel topical formulation, EGYFIL™, for the treatment of pain and stiffness due to muscle contracture, trauma, and/or overtraining. The lotion is composed of hyaluronic acid, a well-known ingredient for the pain alleviation, mixed with skin conditioning SH-Polypeptide-6 and SH-Oligopeptide-1, embedded in it.MethodsTwenty-six patients with pain and/or stiffness were enrolled. After a screening visit (Time 0, t0), patients were treated for the first time with the IP. The treatment consisted of topical application of the pain lotion. Level of pain and stiffness were measured with Numerical Rating Scale (NRS). Patients’ pain and/or stiffness were evaluated at t0 (prior to using the product), after three hours (t1), and after three days (t2) of treatment. Participants were free to apply and re-apply the product ad libitum over the course of the study period (3 days). Potential adverse events (AE) and tolerance were evaluated during each visit.ResultsThere was a 22% decrease in pain in the first three hours (p < 0.001), followed by an additional 20% decrease after three days (p=0.0873). Overall, there was a 42% decrease in pain over the three days of the study (p =0.001). Furthermore, a 24% reduction in stiffness in the first three hours (p=0.025) and a 38% decrease in stiffness over three days (p < 0.001) were observed. Reduction in pain and stiffness were neither age, nor sex dependent. No adverse effects were reported during the study.ConclusionEGYFIL™ is safe and seems to reduce pain and stiffness in patients during the 3 days of treatment, already after 3 h from the first application.Trial registrationClinicalTrials.gov ID: NCT05711953. This trial was registered on 03/02/2023.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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