Objectives: To evaluate the efficacy and safety of innovative BBDE crosslinked low concentrated HMW HA 7 mg/ml (21 mg in stringe 3 ml) associated to antioxidants protective phosphate buffer containing amino acids for the treatment of skin photoaging (J20 Photoaging of the skin according to International Classification of Diseases WHO 11th Revision) of the mid face area by using dermal injections were the aims of that study. Skin quality as non-medical indication was under clinical evaluation during the study.
Introduction: RRS® HA Long Lasting is composed of high molecular weight cross-linked hyaluronic acid associated with amino acids. The brand new UnHeating cross-linking technology is used in creating highly stabilized hyaluronic acid, resistant to degradation and stress, ensuring optimal rheology. HA is biocompatible, biodegradable, nontoxic, ubiquitous across all species no allergic reactions happen with its use, is the main component of ECM.
Materials / method: Prospective, post-marketing, interventional, comparative before-after, single-arm, non-randomized, open-label clinical investigation of the medical device containing viscoelastic, sterile, apyrogenic, buffered, BBDE-crosslinked sodium hyaluronate (HA) associated to antioxidants protective phosphate buffer with amino acids ( RRS HA LONG LASTING, Skin Tech Pharma Group, Spain ) administered to the patients with skin mid facial photoaging in a single session and a follow-up period of up to 28 days.
A total of 52 subjects were recruited and enrolled in the study.
Results: 29 subjects were found suitable for the study . This intervention involved the secondary investigator administered the product. According to the design study, evaluation of the degree of skin photoaging according to the Alexiades-Armenakas scale, wrinkles severity rate (WSRS), aesthetic improvement analysis GAI demonstrated high efficacy of hydrogel in mid face. At 14 days after the use, a notable average reduction of 11 % was observed in the Alexiades-Armenakas scale when compared to the baseline measurement.
Conclusion: The principal aim of this clinical investigation was to assess the efficacy of the RRS® HA LONG LASTING medical device in ameliorating the hydration levels of skin afflicted by photoaging on the mid face. Specifically, this study targeted subjects exhibiting mild to moderate photoaging, as categorized according to the Alexiades-Armenakas classification system, and individuals with nasolabial folds graded between 2 to 4 on the Wrinkle Severity Rating Scale (WSRS). Evaluation of results confirms high efficacy of one single treatment in mid face area and to low risk of adverse events.
Declaraciones
¿Ha recibido algún tipo de financiamiento para realizar su investigación sobre esta temática?
Si
Por favor especifique las entidades (individuo, empresa, sociedad): individual
¿Ha recibido algún pago, honorario u otra compensación por su trabajo acerca de esta investigación?
Si
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¿Tiene vínculos financieros con alguna entidad que podría llegar a competir estrechamente con los medicamentos, materiales o instrumentos tratados en su investigación?
Si
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¿Posee o ha solicitado una patente relacionada a los materiales, productos o instrumentos utilizados en su investigación?
No
Este trabajo es presentado gracias al apoyo de: SKIN TECH PHARMA GROUP , SPAIN