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

NCT ID: NCT04911140

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-30
• Study Completion Date: 2023-12-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Photobiomodulation twice a week

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

Group Type: ACTIVE_COMPARATOR

Photobiomodulation twice a week

Intervention Type: 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 three times a week

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

Group Type: ACTIVE_COMPARATOR

Photobiomodulation three times a week

Intervention Type: 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.

Simulated Photobiomodulation

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

Group Type: PLACEBO_COMPARATOR

Simulated Photobiomodulation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: RADIATION

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nove de Julho University

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 40167796 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36749255 (View on PubMed)

Other Identifiers

FacialRej

Identifier Type: -

Identifier Source: org_study_id