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.
Disclosures
Did you receive any funding to support your research for this TOPIC?
Yes
Please specify entities (individual, company, society): individual
Were you provided with any honoraria, payment or other compensation for your work on this study?
Yes
Please specify entities (individual, company, society): individual
Do you have any financial relationship with any entity which may closely compete with the medications, materials or instruments covered by your study?
Yes
Please specify entities (individual, company, society): individual
Do you own or have you applied for any patents in conjunction with the instruments, medications or materials discussed in your study?
No
This work is presented thanks to the support of: SKIN TECH PHARMA GROUP , SPAIN