Sparavigna Adele, Grimolizzi Franco, Cigni Clara, Lualdi Roberto, Bellia Gilberto
DERMING S.r.l. Milano Italy.
IBSA Farmaceutici Italia Lodi Italy.
Health Sci Rep. 2024 Jan 21;7(1):e1743. doi: 10.1002/hsr2.1743. eCollection 2024 Jan.
Hyaluronic acid (HA)-based injections are used worldwide to improve skin defects associated with aging and ultraviolet light/environmental exposure. HA formulations developed according to molecular weight or with additional components, for example, cross-linking reagents, are limited by their low biological activity and concentration limit. NAHYCO™ technology has enabled the production of hybrid cooperative complexes (HCCs) of low and high molecular weight HA. Developed for injection into the fat compartments of the face and previously demonstrating potential benefits for adipose tissue restoration, Profhilo Structura® is a new 2 mL HCC formulation comprising low molecular weight HA (45 mg/mL) and high molecular weight HA (45 mg/mL). To evaluate the efficacy and tolerability of Profhilo Structura® to restore adipose tissue compartments in the lateral cheek fat compartment.
Fifty healthy enrolled subjects received two injections, 1 month apart, and were evaluated 3 months posttreatment. Investigators performed clinical evaluations (Facial Volume Loss Scale [FVLS] and Wrinkle Severity Rating Scale [WSRS]) at different time points. Subjects also completed self-evaluation assessments following treatment.
A significant improvement in FVLS and WSRS clinical scores after the first treatment was observed; treatment benefit was maintained 3 months after treatment completion and confirmed by subject self-assessment. Most participants reported an improvement, particularly a marked reduction of wrinkles and increased skin firmness. No serious adverse events were reported, confirming the excellent safety profile of HCC injectable devices.
Overall, the study highlighted the efficacy and tolerability of the studied medical device proving its effect on adipose tissue.
基于透明质酸（HA）的注射剂在全球范围内用于改善与衰老以及紫外线/环境暴露相关的皮肤缺陷。根据分子量或添加其他成分（例如交联剂）开发的HA制剂受到其低生物活性和浓度限制的制约。NAHYCO™技术能够生产低分子量和高分子量HA的混合协同复合物（HCC）。Profhilo Structura®是一种新的2毫升HCC制剂，专为注射到面部脂肪层而开发，此前已证明对脂肪组织修复有潜在益处，其包含低分子量HA（45毫克/毫升）和高分子量HA（45毫克/毫升）。旨在评估Profhilo Structura®恢复脸颊外侧脂肪层中脂肪组织隔室的疗效和耐受性。
五十名健康受试者入组，接受两次注射，间隔1个月，并在治疗后3个月进行评估。研究人员在不同时间点进行临床评估（面部体积减少量表[FVLS]和皱纹严重程度评分量表[WSRS]）。受试者在治疗后也完成了自我评估。
首次治疗后观察到FVLS和WSRS临床评分有显著改善；治疗完成3个月后仍保持治疗效果，并得到受试者自我评估的证实。大多数参与者报告有改善，特别是皱纹明显减少，皮肤紧致度增加。未报告严重不良事件，证实了HCC注射装置具有出色的安全性。
总体而言，该研究突出了所研究医疗器械的疗效和耐受性，证明了其对脂肪组织的作用。
