Clinical trial NCT04911140: Comparison of the Effects of Two Frequencies of Application of Photobiomodulation on Facial Rejuvenation
Official title: Comparison of the Effects of Two Frequencies of Application of Photobiomodulation on Facial Rejuvenation: Controlled, Randomized and Double-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Facial Expression
Keywords: photobiomodulation
LED light emitting diode
skin rejuvenation
collagen
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 95
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


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

Primary outcomes:
measure: Changes in the scale of evaluation of wrinkles
timeFrame: Baseline and one month after treatment.
Secondary outcomes:
measure: Changes in wrinkle size (wrinkle width and depth)
timeFrame: Baseline and one month after treatment.
measure: Changes in satisfaction with facial appearance through FACE-Q
timeFrame: Baseline and one month after treatment.
measure: Quantitative evaluation of wrinkles through the measurement of pixels by the Image J software
timeFrame: Baseline and one month after treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
References: