NCT04911140

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

Completed NA Last updated 19 September 2024

What this trial tests

NA trial testing Photobiomodulation twice a week in Wrinkle in 95 participants. Completed in 10 December 2023.

Timeline

30 May 2021

Primary endpoint
10 November 2023

10 December 2023

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	95
Start date	30 May 2021
Primary completion	10 November 2023
Estimated completion	10 December 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Photobiomodulation twice a week
• Photobiomodulation three times a week
• Simulated Photobiomodulation

Conditions studied

• Wrinkle — all drugs for Wrinkle →
• Facial Expression — all drugs for Facial Expression →

Sponsor

University of Nove de Julho

Who can join

Adults 45 to 60, female only, with Wrinkle or Facial Expression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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%.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of the effects of 2 frequencies of application of photobiomodulation on facial rejuvenation: Controlled, randomized, and double-blind clinical trial.
   Bragato EF, Pires JA, Momolli M, Guerra MB, et al · · 2023 · cited 2× · PMID 36749255 · DOI 10.1097/md.0000000000032514