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临床试验/NCT07359924
NCT07359924已完成2 期

Application of Liquid Fraction of Platelet-rich Fibrin in Face Care Cream.

Poznan University of Medical Sciences0 个研究点目标入组 20 人开始时间: 2022年2月3日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
20

研究概览

简要总结

The study evaluates the effectiveness of cosmetic preparations containing PRF, conducted through in vivo studies. Material and Methods: The study involved 20 healthy volunteers (aged 20-40) who received three identically packaged creams to be applied to specific facial areas. Formulation 1: base formulation (control), Formulation 2: base formulation with human epidermal growth factor (EGF), and Formulation 3: base formulation with platelet-rich fibrin (PRF). Volunteers applied the creams as directed for a period of four weeks. Skin assessments was conducted at baseline (week 0), and at weeks 1, 2, and 4. Trans-epidermal Water Loss (TEWL), skin hydration using corneometry to determine the moisture content of the stratum corneum, skin elasticity using a cutometer to measure the skin's ability to return to its original state after deformation, and dermal bioavailability were measured. EGF concentration in the stratum corneum will be measured using the tape-stripping method followed by HPLC (High-Performance Liquid Chroma-tography) analysis. Results: A significant decrease in TEWL was observed in formulations 2 and 3, indicating improved skin barrier function. Formulation 3 showed the highest increase in skin hy-dration, followed by formulation 2. Both formulations 2 and 3 demonstrated improvements in skin elasticity, with formulation 3 showing the greatest enhancement. EGF concentration in the stratum corneum increased over the four-week period, reaching equilibrium with the product concentration by week four. Con-clusion: The in vivo instrumental compatibility studies confirmed that the new cosmetic formulations containing EGF and PRF are safe and effective for human skin.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Every patients have got identically looking boxes with different creams formulation, signed by following numbers and the instruction for specific application. Every patient received the same instruction.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy volunteers with healthy skin, who sign an agreement for study participation

排除标准

  • systemic diseases, smoking, blood disorders, acute viral infections and skin inflammations, pregnancy, and breastfeeding.

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

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