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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
95
The photobiomodulation will be applied with a LED facial mask, Cosmedical brand (São Paulo, Brazil), containing 92 red LEDs, 660 nm of wavelength, in continuous mode for 21 minutes, twice a week, for 4 weeks.
The photobiomodulation will be applied with a LED facial mask, Cosmedical brand (São Paulo, Brazil), containing 92 red LEDs, 660 nm of wavelength, in continuous mode for 21 minutes, three times a week, for 4 weeks.
Photobiomodulation will be simulated, with the device turned off, twice a week, for 4 weeks. The characteristic sound of the device will be triggered by recording.
Nove de Julho University
São Paulo, São Paulo, Brazil
Changes in the scale of evaluation of wrinkles
The evaluation of wrinkles will be carried out in a standardized way using the Wrinkle Assessment Scale. In a specific and reserved room, digitalized photographs of the face will be taken in the positions: front, 45 degrees right and left with Canon digital camera model SX510 HS 12.1 MP, using white LED lighting, turquoise blue background, 50cm face distance, manual macro mode, standard that will be followed in the photographs after one month of treatment. The images will be distributed to the three plastic surgeons who will classify them according to the scale of wrinkles and photographic models pre-defined. Each evaluator will receive the same image of wrinkles, all at the end of the experiment. Each image should receive a score from 0 (no wrinkles) to 5 (very deep wrinkles) using the Wrinkle Assessment Scale. The data obtained will be grouped and the evolutionary comparison will be made according to the group of the patient under study.
Time frame: Baseline and one month after treatment.
Changes in wrinkle size (wrinkle width and depth)
Before treatment and after 1 month, molds of the frontal lines will be made with light condensation silicone (Clonage, DFL Indústria e Comércio, RJ, Brazil). The silicone mold obtained will be poured into special plaster in a short time. Plaster models will be sent for optical coherence tomography analysis and wrinkle width and depth measured before treatment and after 1 month.
Time frame: Baseline and one month after treatment.
Changes in satisfaction with facial appearance through FACE-Q
Participants will answer the FACE-Q questionnaire (satisfaction with facial appearance, adapted for the Portuguese language). FACE-Q is a tool developed to measure the impact and effectiveness of facial aesthetic procedures from the patients' perspective.The results will be tabulated and evaluated according to the sum of the scores obtained in the 10 questions. The higher the score, the more satisfied.
Time frame: Baseline and one month after treatment.
Quantitative evaluation of wrinkles through the measurement of pixels by the Image J software
In a specific and reserved room, digitalized photographs of the face will be taken in the positions: front, 45 degrees right and left with Canon digital camera model SX510 HS 12.1 MP, using white LED lighting, turquoise blue background, 50cm face distance and manual macro mode. The quantification in pixels of wrinkles on the forehead, glabellar region, periorbital region and nasolabial fold will be analyzed with Image J software before and after one month of treatment.
Time frame: Baseline and one month after treatment.
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