proDERM Institute for Applied Dermatological Research, Schenefeld-Hamburg, Germany.
J Med Food. 2020 Feb;23(2):147-152. doi: 10.1089/jmf.2019.0197.
The purpose of this randomized, placebo-controlled, triple-blind trial on 60 healthy female volunteers was to assess the cosmetic effects on skin quality of a food supplement containing special collagen peptides together with acerola extract, vitamin C, vitamin E, biotin, and zinc after an intake of 12 weeks (Elasten, QUIRIS Healthcare, Germany). To reduce assessment bias maximally and increase the accuracy and objectivity of the outcomes, the trial design was triple blinded in a manner that neither the subjects nor the person administering the products nor the person who assessed the primary outcomes knew which subjects had received the test product and which had received the placebo. The expert grader assessing the confocal laser scanning microscopy images was additionally blinded regarding the time when the image was taken (on days 1 or 85). The objective, blinded, and validated image analyses using confocal laser scanning microscopy showed a significant improvement of the collagen structure of facial skin (primary endpoint) after intake of the test product, while no improvements were found after intake of the placebo. The proven positive nutritional effect on the collagen structure was fully consistent with positive subjective evaluations of relevant skin parameters such as elasticity, crinkliness/wrinkliness, and evenness in different body areas such as face, hands, décolleté, neck, backside, legs, and belly, all serving as secondary endpoints. The test product was found to be safe and very well tolerated. A cosmetically relevant improvement of the facial skin was demonstrated after administration of the collagen supplement.
本项随机、安慰剂对照、三盲临床试验纳入了 60 名健康女性志愿者,旨在评估摄入 12 周特殊胶原蛋白肽与樱桃提取物、维生素 C、维生素 E、生物素和锌的膳食补充剂对面部皮肤质地的美容效果(Elasten,QUIRIS Healthcare,德国)。为了最大程度地减少评估偏差,提高结果的准确性和客观性,试验设计采用三盲法,即受试者、产品给药者和主要结局评估者均不知道哪些受试者接受了试验产品,哪些接受了安慰剂。评估共聚焦激光扫描显微镜图像的专家评分者还对图像拍摄时间(第 1 天或第 85 天)进行了盲法处理。使用共聚焦激光扫描显微镜进行客观、盲法和验证的图像分析显示,在摄入试验产品后,面部皮肤的胶原结构显著改善(主要终点),而摄入安慰剂后则无改善。对胶原结构的阳性营养作用与弹性、皱纹/起皱和不同身体部位(如面部、手部、颈部、背部、腿部和腹部)的均匀性等相关皮肤参数的阳性主观评估完全一致,这些都作为次要终点。试验产品被证明是安全且耐受性良好的。在给予胶原蛋白补充剂后,面部皮肤的美容效果得到了改善。