Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.
Postgraduate Program in Rehabilitation Sciences, Universidade Nove de Julho (UNINOVE), São Paulo, Brazil.
Medicine (Baltimore). 2023 Feb 3;102(5):e32514. doi: 10.1097/MD.0000000000032514.
Skin aging is an irreversible, slow and progressive process, mainly influenced by age, but also by external factors such as ultraviolet radiation, smoking, and alcohol, among others. It is increasingly common to look for procedures that slow down skin aging by limiting or hiding its effects on appearance. Studies have shown the benefits of photobiomodulation (PBM) for the skin, especially with the use of red light-emitting diodes. However, there is a high level of variability in the treatment parameters and frequency of application.
The objective of this study is to compare the effects of PBM with a light-emitting diode mask (660 nm, 6.4 mW/ cm², 8,02 J/ cm², 5.02 mW, 21 minutes) on facial rejuvenation using 2 frequency applications for 4 weeks: one group will receive PBM application on the face, twice a week and another group will receive PBM application 3 times a week. A group with simulated PBM applied twice a week for 4 weeks will be used as a control. The treatment will be performed on female participants aged between 45 and 60 years. After 4 weeks, evaluations of photographic images by specialists (Wrinkle Assessment Scale) as well as the quantitative analysis of the wrinkle size by the Image J software, the depth and width of wrinkles (assessment of face impressions by optical coherence tomography) and the level of Satisfaction with Facial Appearance Overall will be compared with data collected before the start of the study. All data will be analyzed statistically according to their distribution, seeking a level of statistical significance of 0.05.
This protocol was approved by the Research Ethics Committee of the Nove de Julho University (acceptance number: 4.365.565). This trial has been registered in ClinicalTrials.gov (ID: NCT04911140). This study is recruiting.
皮肤衰老(Skin aging)是一个不可逆转、缓慢且渐进的过程,主要受年龄影响,但也受其他因素影响,如紫外线辐射、吸烟和饮酒等。为了减缓皮肤衰老速度,限制或隐藏其对外貌的影响,人们越来越多地寻求各种方法。研究表明,光生物调节(Photobiomodulation,PBM)对皮肤有益,特别是使用红光发光二极管(Light-Emitting Diode,LED)。然而,在治疗参数和应用频率方面存在很大的变异性。
本研究的目的是比较 PBM 与发光二极管面膜(660nm,6.4mW/cm²,8.02J/cm²,5.02mW,21 分钟)对面部年轻化的影响,使用 4 周内 2 种频率应用:一组将接受每周两次的 PBM 面部应用,另一组将每周接受 PBM 应用 3 次。每周应用 PBM 两次 4 周的模拟 PBM 组将作为对照组。治疗将在年龄在 45 至 60 岁之间的女性参与者中进行。4 周后,由专家对照片图像进行评估(皱纹评估量表),并使用 Image J 软件对皱纹大小进行定量分析,通过光学相干断层扫描评估面部印象的皱纹深度和宽度(皱纹评估)以及对整体面部外观的满意度,将与研究开始前收集的数据进行比较。所有数据将根据其分布进行统计分析,寻求 0.05 的统计学意义水平。
该方案已获得诺维德朱尼奥大学研究伦理委员会的批准(接受编号:4.365.565)。本试验已在 ClinicalTrials.gov 注册(ID:NCT04911140)。本研究正在招募中。