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

NCT04911140 | Completed

• 1 other identifier: FacialRej
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Wrinkle; Facial Expression

Keywords

photobiomodulation; LED light emitting diode; skin rejuvenation; collagen

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and one month after treatment.

Secondary Outcomes (3)

• Changes in wrinkle size (wrinkle width and depth)

  Baseline and one month after treatment.

• Changes in satisfaction with facial appearance through FACE-Q

  Baseline and one month after treatment.

• Quantitative evaluation of wrinkles through the measurement of pixels by the Image J software

  Baseline and one month after treatment.

Study Arms (3)

Photobiomodulation twice a week

ACTIVE COMPARATOR

This group will receive the application of photobiomodulation (PBM) twice a week for 4 weeks.

Radiation: Photobiomodulation twice a week

Photobiomodulation three times a week

ACTIVE COMPARATOR

This group will receive the application of photobiomodulation (PBM) three times a week for 4 weeks.

Radiation: Photobiomodulation three times a week

Simulated Photobiomodulation

PLACEBO COMPARATOR

This group will receive the application of simulated photobiomodulation (PBM) twice a week for 4 weeks.

Other: Simulated Photobiomodulation

Interventions

Photobiomodulation twice a week RADIATION

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.

Photobiomodulation twice a week

Photobiomodulation three times a week RADIATION

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 three times a week

Simulated Photobiomodulation OTHER

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.

Simulated Photobiomodulation

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female volunteers aged 45 to 60 years;
• At menopause (at least 12 months without menstruation);
• Healthy;
• Skin phototype I to IV by Fitzpatrick classification;
• Visible signs of skin aging grades III and IV of the Glogau scale.

You may not qualify if:

• With a history of photosensitivity.
• Who have any type of lesion on the skin of the face.
• Who use corticosteroids, anticoagulants, or any drug known to increase photosensitivity, including systemic retinoids and use of topical retinoic acid in the last 6 months.
• People with any collagen-related diseases, malnutrition, anemia, immunosuppression, cancer diseases, smokers, predisposition to hypertrophic and keloid scarring, history of dermatological diseases, surgery on the face, trauma to the face, diseases that could affect the condition of the skin and disease psychiatric.
• Who are in the menstrual period, in the climacteric or in hormone replacement therapy.
• Who underwent cosmetic procedures on the face, such as application of botulinum toxin in the last 8 months, facial filling in the last year, chemical peels, ablative laser and dermabrasion in the last 6 months.
• Who do not respect the post treatment recommendations or who fail to attend a treatment session.
• Those that, during the procedures, present any type of complication (hypersensitivity, allergies) will not be part of the statistical analysis, as these cases will not be in the expected pattern for these procedures. However, these data will be described and discussed, as well as the possible adverse effects and the participants will receive treatment to resolve the condition

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, São Paulo, 01525-000, Brazil

Location

Related Publications (2)

• Bragato EF, Paisano AF, Pavani C, Motta LJ, Varellis MLZ, Chiedde M, da Silva GA, Bussadori SK, Mesquita-Ferrari RA, Fernandes KPS. Role of photobiomodulation application frequency in facial rejuvenation: randomized, sham-controlled, double-blind, clinical trial. Lasers Med Sci. 2025 Apr 1;40(1):170. doi: 10.1007/s10103-025-04383-1.

  PMID: 40167796 DERIVED

• Bragato EF, Pires JA, Momolli M, Guerra MB, Paisano AF, Ferrari RAM, Bussadori SK, Motta LJ, Fernandes KPS. Comparison of the effects of 2 frequencies of application of photobiomodulation on facial rejuvenation: Controlled, randomized, and double-blind clinical trial. Medicine (Baltimore). 2023 Feb 3;102(5):e32514. doi: 10.1097/MD.0000000000032514.

  PMID: 36749255 DERIVED

MeSH Terms

Conditions

Facial Expression

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Pre and post treatment assessments will be made by three examiners (three plastic surgeons) who will not be aware of the group in which each patient will be allocated. Participants will not be aware of whether or not they have received the application of the FBM, as they will be using ocular sales. The person responsible for the application will position the equipment in the irradiation locations in all participants and will only activate the light when provided for in the specific experimental group. The characteristic sound of the device will be triggered by recording in the placebos groups for the PBM.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 2, 2021
• Study Start: May 30, 2021
• Primary Completion: November 10, 2023
• Study Completion: December 10, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)