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Comparison of the Effects of Two Frequencies of Application of Photobiomodulation on Facial Rejuvenation

Wrinkle Clinical Trial

Official title:
Comparison of the Effects of Two Frequencies of Application of Photobiomodulation on Facial Rejuvenation: Controlled, Randomized and Double-Blind Clinical Trial

Clinical Trial Summary

Skin aging is an irreversible, slow and progressive process, being influenced mainly by age, but also by external factors such as ultraviolet radiation, smoking, alcohol, among others. Studies have shown benefits of photobiomodulation for facial rejuvenation, especially with the use of red LED. However, there is still a high level of variability in treatment parameters and frequency of application of FBM. The purpose of this study is to compare the effects of photobiomodulation with LED mask (660nm, 6.4 mW/cm², 2.67 J/cm², 5.02 mW, 21 min) on facial rejuvenation using 2 application frequencies: a group will receive 2 weekly applications for 4 weeks and another group will receive 3 weekly applications for the same period. A group with simulated photobiomodulation applied twice a week for 4 weeks will be used as a control. The treatment will be performed in female participants aged between 45 and 60 years. After a period of one month, the depth and width of wrinkles (assessment of face impressions by optical coherence tomography), evaluations of photographic images by specialists (Wrinkle Assessment Scale), as well as the quantitative analysis of the wrinkle size by the Image J software and the level of satisfaction of the participants (FACE-Q) will be compared with data collected before the start of the study. All data will be statistically analyzed according to their distribution, seeking a level of statistical significance of 5%.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04911140
Study type Interventional
Source University of Nove de Julho
Contact Sandra K Bussadori, PhD
Phone +55 11 2633-9000
Email sandra.skb@gmail.com
Status Recruiting
Phase Phase 2
Start date May 30, 2021
Completion date January 30, 2023
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