Kerscher Martina, Wagner-Schiffler Sylvia, Noah Ernst Magnus, Fischer Tanja, Greiner-Krüger Daniela, Sattler Sonja, Kaptan Tanju, Drabik Attyla, Hamed Glyn, Reinecke Julio, Wehling Jana
Division of Cosmetic Sciences, University of Hamburg, Hamburg, Germany.
Dermatologische Praxis, Aachen, Germany.
Clin Cosmet Investig Dermatol. 2022 Jun 27;15:1157-1173. doi: 10.2147/CCID.S357810. eCollection 2022.
The "Inflammation Theory of Ageing" identifies pro-inflammatory cytokines and oxidative damage as one cause of cellular and mitochondrial deterioration and aging. Cell-free blood cell secretome (BCS) also known as autologous conditioned serum (ACS) has shown anti-inflammatory and regenerative mode of action in musculoskeletal disorders and radicular compression.
To confirm that BCS can improve signs of skin aging from a previous study in a multi-center setting.
Prospective, one-armed, multi-center interventional therapeutic study. Ninety-five women with skin firmness loss were treated with four intra-dermal injection sessions in both cheeks at 0, 2, 4 and 6 weeks. BCS was processed with Exokine® medical device according to manufacturer's instructions. Primary endpoints were cutometric R0 and R3 at 12 and 24 weeks. GAIS, FACE-Q, Patient Attractivity Self-Assessment and safety were evaluated.
Mean skin firmness (R0) improved significantly from baseline 0.40 mm to 0.38 mm at week 12 and to 0.36 mm at week 24. Mean skin tiring (R3) improved significantly from baseline 0.45 mm to 0.42 mm at week 12 and to 0.40 at week 24. FACE-Q "Satisfaction with Skin" significantly improved from baseline to weeks 12, 24 and 48. So did "Satisfaction with Facial Appearance" and "Psychological and Social Function". "Satisfaction with Decision" and "Satisfaction with Outcome" were stable at week 24 and 48. At week 48 patients assessed their age 1.68 years younger vs Baseline. FACE-Q aging appraisal improves from Baseline 52.94 to 65.23 at week 48. GAIS, by both physicians and patients, confirm improvement of skin.
For up to 48 weeks four intra-dermal injections with cell-free BCS increase facial skin firmness and resilience to tiring and patients' satisfaction with their facial appearance and skin. Patients perceive their face as younger. BCS has the ability to sustainably rejuvenate facial skin safely.
Registration on German clinical trials register: DRKS00013014.
“衰老炎症理论”认为促炎细胞因子和氧化损伤是细胞和线粒体退化及衰老的原因之一。无细胞血细胞分泌组(BCS),也称为自体条件血清(ACS),已在肌肉骨骼疾病和神经根压迫中显示出抗炎和再生作用模式。
在前一项研究的基础上,在多中心环境中证实BCS可改善皮肤衰老迹象。
前瞻性、单臂、多中心介入治疗研究。95名皮肤紧致度下降的女性在第0、2、4和6周时在双颊进行了4次皮内注射治疗。BCS使用Exokine®医疗器械按照制造商说明进行处理。主要终点是第12周和24周时的皮肤测量R0和R3。对全球美学改善量表(GAIS)、面部质量问卷(FACE-Q)、患者吸引力自我评估和安全性进行了评估。
平均皮肤紧致度(R0)从基线的0.40毫米在第12周时显著改善至0.38毫米,在第24周时改善至0.36毫米。平均皮肤疲劳度(R3)从基线的0.45毫米在第12周时显著改善至0.42毫米,在第24周时改善至0.40毫米。FACE-Q“对皮肤的满意度”从基线到第12周、24周和48周时显著改善。“对面部外观的满意度”以及“心理和社会功能”也是如此。“对决策的满意度”和“对结果的满意度”在第24周和48周时保持稳定。在第48周时,患者评估自己的年龄比基线时年轻1.68岁。FACE-Q衰老评估从基线的52.94提高到第48周时的65.23。医生和患者的GAIS均证实皮肤有所改善。
在长达48周的时间里,4次皮内注射无细胞BCS可增加面部皮肤紧致度和抗疲劳能力,并提高患者对面部外观和皮肤的满意度。患者感觉自己的脸更年轻了。BCS有能力安全且可持续地使面部皮肤焕发生机。
在德国临床试验注册中心注册:DRKS00013014。