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

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

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 Overview

• Status: Recruiting
• Conditions: Wrinkle; Facial Expression
• Intervention / Treatment: Radiation: Photobiomodulation twice a week; Radiation: Photobiomodulation three times a week; Other: Simulated Photobiomodulation

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01525-000
    • Recruiting
    • Nove de Julho University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Photobiomodulation twice a week; This group will receive the application of photobiomodulation (PBM) twice a week for 4 weeks.	Radiation: Photobiomodulation twice a week; 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.
ACTIVE_COMPARATOR: Photobiomodulation three times a week; This group will receive the application of photobiomodulation (PBM) three times a week for 4 weeks.	Radiation: Photobiomodulation three times a week; 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.
PLACEBO_COMPARATOR: Simulated Photobiomodulation; This group will receive the application of simulated photobiomodulation (PBM) twice a week for 4 weeks.	Other: Simulated Photobiomodulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and one month after treatment.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2021
• Primary Completion (ANTICIPATED): December 10, 2022
• Study Completion (ANTICIPATED): January 30, 2023

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (ACTUAL): June 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: collagen; photobiomodulation; skin rejuvenation; LED light emitting diode
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Facies
• Other Study ID Numbers: FacialRej

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No