WrinkleNCT04911140
Comparison of the Effects of Two Frequencies of Application of Photobiomodulation on Facial Rejuvenation
A study testing Photobiomodulation twice a week, Photobiomodulation three times a week and Simulated Photobiomodulation in people with Wrinkle and Facial Expression, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Wrinkle, Facial Expression
- What is being tested?
- Photobiomodulation twice a week, Photobiomodulation three times a week and Simulated Photobiomodulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteBrazil
- Study dates
- 30 May 2021to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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%.
- Conditions
- Wrinkle, Facial Expression
- Being tested
- Photobiomodulation twice a week, Photobiomodulation three times a week, Simulated Photobiomodulation
- Keywords
- photobiomodulation, LED light emitting diode, skin rejuvenation, collagen
- Medical subject headings
- Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation twice a weekRadiation
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 weekRadiation
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 PhotobiomodulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation twice a week | Active comparator | This group will receive the application of photobiomodulation (PBM) twice a week for 4 weeks. Receives: 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. Receives: 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. Receives: Other: Simulated Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and one month after treatment.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and one month after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start30 May 2021
- Primary completion10 Nov 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911140
- Sponsor's protocol ID
- FacialRej
- Status last verified
- Sep 2024
- First submitted
- 20 May 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40167796Bragato 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.
PubMed 36749255
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Two Frequencies of Application of Photobiomodulation on Facial Rejuvenation: Controlled, Randomized and Double-Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04911140
- Acronym / sponsor ID
- FacialRej
- Conditions
- Wrinkle, Facial Expression
- Keywords
- photobiomodulation, LED light emitting diode, skin rejuvenation, collagen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation twice a week | Active comparator | Radiation: Photobiomodulation twice a weekThis group will receive the application of photobiomodulation (PBM) twice a week for 4 weeks. |
| Photobiomodulation three times a week | Active comparator | Radiation: Photobiomodulation three times a weekThis group will receive the application of photobiomodulation (PBM) three times a week for 4 weeks. |
| Simulated Photobiomodulation | Placebo comparator | Other: Simulated PhotobiomodulationThis group will receive the application of simulated photobiomodulation (PBM) twice a week for 4 weeks. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photobiomodulation twice a weekThe 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. | Radiation | Photobiomodulation twice a week |
| Photobiomodulation three times a weekThe 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. | Radiation | Photobiomodulation three times a week |
| Simulated PhotobiomodulationPhotobiomodulation 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. | Other | Simulated Photobiomodulation |
Primary outcome
Changes in the scale of evaluation of wrinkles
Time frame: Baseline and one month after treatment.
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.
3 secondary outcomes
Changes in wrinkle size (wrinkle width and depth)
Time frame: Baseline and one month after treatment.
Changes in satisfaction with facial appearance through FACE-Q
Time frame: Baseline and one month after treatment.
Quantitative evaluation of wrinkles through the measurement of pixels by the Image J software
Time frame: Baseline and one month after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40167796Bragato 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.
- Derived from this study: PubMed 36749255Bragato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation twice a week, Photobiomodulation three times a week and Simulated Photobiomodulation in people with Wrinkle and Facial Expression, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the scale of evaluation of wrinkles (time frame: Baseline and one month after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04911140, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.