PDF(Pubmed)
Abstract：
UNASSIGNED: The objective of this study is three-fold. Firstly, to evaluate an enhanced vitamin C serum (eVCS) and its\' combination with a retinol-bakuchiol serum (RBS) on pigmentation in vitro. Secondly, to evaluate the effect of the eVCS on skin function ex vivo. Lastly, to evaluate eVCS and RSB in the treatment of facial hyperpigmentation and overall photodamage across a range of opposing environments.
UNASSIGNED: MelanoDerm™ tissues were topically treated with the eVCS, and a eVCS and RSB blend for 14 days, and then a melanin assay was performed. Surgical waste facial skin explants were incubated with the eVCS or control for five days and then fixed and stained for skin physiology and structure. A 12-week, IRB approved, study on female subjects (n=29, aged 35 to 65) with moderate global facial hyperpigmentation and overall photodamage was completed. Clinical assessment, tolerability measurements, and subject-assessments were performed baseline at Weeks 6, 8, and 12. Investigator Global Aesthetic Improvement Score was completed at Week 12.
UNASSIGNED: The eVCS-treated facial skin explants achieved a significant 145 percent collagen increase compared to control. The eVCS-RSB combination proved synergistic in reducing melanin compared to the eVCS alone. The eVCS-RSB combination demonstrated significant clinical improvement at all timepoints and was well tolerated. Subject responses were favorable and GAIS score of 3.0 was achieved at Week 12, indicating an improvement.
UNASSIGNED: Limitations include lack of placebo or vehicle control.
UNASSIGNED: The product pairing, eVCS and RSB, offers patients an efficacious and well-tolerated treatment to target pigmentation and photodamage.
UNASSIGNED: This study, Pro00050557, was approved by Advarra IRB (Columbia, Maryland) and submitted to ClinicalTrials.gov #: NCT05423873.
UNASSIGNED: MelanoDerm™ tissues were topically treated with the eVCS, and a eVCS and RSB blend for 14 days, and then a melanin assay was performed. Surgical waste facial skin explants were incubated with the eVCS or control for five days and then fixed and stained for skin physiology and structure. A 12-week, IRB approved, study on female subjects (n=29, aged 35 to 65) with moderate global facial hyperpigmentation and overall photodamage was completed. Clinical assessment, tolerability measurements, and subject-assessments were performed baseline at Weeks 6, 8, and 12. Investigator Global Aesthetic Improvement Score was completed at Week 12.
UNASSIGNED: The eVCS-treated facial skin explants achieved a significant 145 percent collagen increase compared to control. The eVCS-RSB combination proved synergistic in reducing melanin compared to the eVCS alone. The eVCS-RSB combination demonstrated significant clinical improvement at all timepoints and was well tolerated. Subject responses were favorable and GAIS score of 3.0 was achieved at Week 12, indicating an improvement.
UNASSIGNED: Limitations include lack of placebo or vehicle control.
UNASSIGNED: The product pairing, eVCS and RSB, offers patients an efficacious and well-tolerated treatment to target pigmentation and photodamage.
UNASSIGNED: This study, Pro00050557, was approved by Advarra IRB (Columbia, Maryland) and submitted to ClinicalTrials.gov #: NCT05423873.
摘要：
■这项研究的目的是三方面的。首先,在体外评估增强的维生素C血清（eVCS）及其与视黄醇-bakuchiol血清（RBS）的组合对色素沉着的影响。其次,评估eVCS对离体皮肤功能的影响。最后,评估eVCS和RSB在一系列相反环境中面部色素沉着过度和整体光损伤的治疗。
■用eVCS局部治疗MelanoDerm™组织，eVCS和RSB混合14天，然后进行黑色素测定。将手术废物面部皮肤外植体与eVCS或对照一起孵育五天，然后固定并染色皮肤生理和结构。12周,IRB批准，完成了对女性受试者（n=29，年龄35至65岁）的中度整体面部色素沉着和整体光损伤的研究。临床评估,耐受性测量，受试者评估在第6、8和12周进行基线。研究者全球美学改善评分在第12周完成。
经eVCS处理的面部皮肤外植体与对照相比实现了145%的显著胶原蛋白增加。与单独的eVCS相比,eVCS-RSB组合证明在减少黑色素方面具有协同作用。eVCS-RSB组合在所有时间点表现出显著的临床改善,并且具有良好的耐受性。受试者反应是有利的,并且在第12周时达到3.0的GAIS评分,表明改善。
■限制包括缺乏安慰剂或媒介物对照。
■产品配对，eVCS和RSB，为患者提供有效和耐受性良好的治疗目标色素沉着和光损伤。
■这项研究，Pro00050557，由AdvarraIRB(哥伦比亚，马里兰州）并提交给ClinicalTrials.gov#：NCT05423873。
■用eVCS局部治疗MelanoDerm™组织，eVCS和RSB混合14天，然后进行黑色素测定。将手术废物面部皮肤外植体与eVCS或对照一起孵育五天，然后固定并染色皮肤生理和结构。12周,IRB批准，完成了对女性受试者（n=29，年龄35至65岁）的中度整体面部色素沉着和整体光损伤的研究。临床评估,耐受性测量，受试者评估在第6、8和12周进行基线。研究者全球美学改善评分在第12周完成。
经eVCS处理的面部皮肤外植体与对照相比实现了145%的显著胶原蛋白增加。与单独的eVCS相比,eVCS-RSB组合证明在减少黑色素方面具有协同作用。eVCS-RSB组合在所有时间点表现出显著的临床改善,并且具有良好的耐受性。受试者反应是有利的,并且在第12周时达到3.0的GAIS评分,表明改善。
■限制包括缺乏安慰剂或媒介物对照。
■产品配对，eVCS和RSB，为患者提供有效和耐受性良好的治疗目标色素沉着和光损伤。
■这项研究，Pro00050557，由AdvarraIRB(哥伦比亚，马里兰州）并提交给ClinicalTrials.gov#：NCT05423873。
