WrinklePhase 2NCT04145999

Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation

A Phase 2 study testing PRP application and Photobiomodulation in people with Wrinkle, run by University of Nove de Julho.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 45 to 60 years, women onlyHealthy volunteers can take part
Conditions the study is for: Wrinkle
What is being tested?: PRP application and Photobiomodulation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: No sites listed yet
Study dates: 10 Jan 2020to 10 Dec 2021
Phase: Phase 2
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

Menopause (at least 12 months without menstruation);
Healthy;
Skin phototype from I to IV by Fitzpatrick classification.

Who cannot join

History of photosensitivity;
Use of corticosteroids, anticoagulants, or any drug known to increase photosensitivity, including systemic retinoids and topical retinoic acid use for the past 6 months;
Carriers of any collagen-related diseases, malnutrition, anemia, immunosuppression, cancer diseases, smokers, predisposition to hypertrophic and keloid scarring, history of dermatological diseases, facial surgery, facial trauma, conditions that could affect skin condition and psychiatric diseases;
Patients with blood dyscrasias and thrombocytopenia;
Esthetic procedures on the face, such as botulinum toxin application in the last year, facial filling in the last 2 years, chemical peels, ablative laser and dermabrasion in the last year;
Those who do not comply with post-treatment recommendations or fail to attend a treatment session;
During the procedures those who present any type of complication (hematoma, 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 possible adverse effects ,and participants will receive treatment to solve the condition.

About this study

Official title: Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation: Controlled, Randomized Clinical Trial

Skin aging is an irreversible, slow and progressive process. It is influenced mainly by age, but also by external factors such as ultraviolet radiation, smoking, alcohol, among others. It is increasingly common to look for procedures that slow this process by limiting or hiding its effects on the skin and its appearance. Intradermal platelet-rich plasma (PRP) injection is a new modality of treatment which has possible beneficial effects on skin rejuvenation. In addition, studies have shown photobiomodulation (PBM) benefits to the skin. The purpose of this paper is to investigate the effects of combined use of intradermal PRP injection on the face and photobiomodulation for facial rejuvenation. To this end, a randomized, double-blind, controlled clinical trial will be conducted with volunteer participants who wish to improve facial aesthetics, attended at the Nove de Julho University specialty medical outpatient clinic in the city of São Paulo. Participants will be divided into three groups: one group will undergo intradermal application of PRP in association with PBM; another group will undergo intradermal application of PRP and placebo light and a third group will receive intradermal application of 0.9% saline solution (placebo) associated with PBM. Only one application of PRP or saline solution will be performed at defined points on the face. PBM sessions will be held immediately after the first application of PRP or saline solution, 3 days after the first application and weekly for the next 3 weeks. The following variables will be studied for further analysis: face moldings analyzed by optical coherence tomography; skin viscoelasticity; histological study of the dermis; evolutionary comparison of photographic images by plastic surgeons (Wrinkle Assessment Scale) and participants' satisfaction level (FACE-Q). All data will be statistically evaluated according to their distribution.

Conditions: Wrinkle
Being tested: PRP application, Placebo PRP application, Photobiomodulation, Placebo Photobiomodulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRP applicationProcedure or surgery
The study participant will receive topical anesthesia with lidocaine ointment (50mg/g). After 5 minutes the face will be cleaned with 0.5% alcohol chlorhexidine solution. The newly obtained platelet-rich plasma activated with 10% calcium chloride packed in a 5mL syringe will be applied to the face using a 30G needle in the frontal, lateral periorbital, nasogenian sulcus, bilateral malar region and an infra-auricular point. 0.1ml per cm2 will be injected, totaling 43 points. Only one application of PRP will be performed at the defined points.
Placebo PRP applicationOther
Blood collection will be performed normally, the time between collection and application of saline will be the same as the PRP protocol, but in this case, the blood will be discarded, only a sample to quantify the number of platelets will be sent for analysis.
PhotobiomodulationRadiation
Photobiomodulation will be applied with a Cosmedical LED face mask (São Paulo, Brazil) containing 92 red LEDs. The applications will occur in the experimental periods of 0, 3, 7, 14, 21 and 28 days after the application of PRP or placebo.
Placebo PhotobiomodulationOther
Participants will not be aware of whether or not they have received the PBM application as they will be using eye protection and the researcher will position the equipment at the irradiation locations on all participants. The characteristic sound of the device will be triggered by recording in the placebos groups for the PBM. The placebo applications will occur in the experimental periods of 0, 3, 7, 14, 21 and 28 days after the application of PRP.

Study groups in NCT04145999
Study group	Role	What they receive
PRP + PBM group	Experimental	This group will receive both PRP application and photobiomodulation. Receives: Procedure: PRP application; Radiation: Photobiomodulation
PRP + placebo PBM	Experimental	This group will receive PRP application and placebo photobiomodulation. Receives: Procedure: PRP application; Other: Placebo Photobiomodulation
PBM + placebo PRP	Experimental	This group will receive placebo PRP application with a saline solution and active photobiomodulation. Receives: Other: Placebo PRP application; Radiation: Photobiomodulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Photographic Analysis
Digital photographs of the face obtained before and after 3 and 6 months will be analyzed by 3 plastic surgeons. Each evaluator will receive the same image of wrinkles, all at the end of the experiment. There will be 15 standardized photographs of the face per patient over 6 months of study, totaling 1440 images for each evaluator. Each image should be scored from 0 to 5 using the Wrinkle Assessment Scale.
Measured: Baseline, 3 months and 6 months after treatment.

Secondary outcomes (4)

Change in Optical Coherence Tomography (OCT) Analysis
Negative silicone molds of frontal wrinkles, bilateral periorbital wrinkles and nasolabial folds will be analyzed before treatment and after 3 and 6 months. The parameters to be analyzed are: average surface roughness; average roughness and maximum profile height.
Measured: Baseline, 3 months and 6 months after treatment.
Change in Skin Viscoelasticity
It will be evaluated in the periocular and bilateral malar region by CUTOMETER DUAL MPA 580® (CK ELETRONIC). The ability of the skin to return to its original position is translated into a measure of elasticity using the device's own software.
Measured: Baseline and 3 months after treatment.
Change in Histological Analysis
Analysis that will be performed by the same pathologist before and after 6 months of treatment. The following parameters will be quantified and compared: epidermal dermal junction length; number of fibroblasts per papillary dermis area; number of blood vessels per basement membrane area; density of collagen fibers by area and density of elastic fibers by area.
Measured: Baseline and 6 months after treatment.
Change of Satisfaction with Facial Appearance
Participants will answer the FACE-Q questionnaire, that ranks Satisfaction with Facial Appearance.
Measured: Baseline, 3 months and 6 months after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202010 Dec 2021

First posted31 Oct 2019
Study start10 Jan 2020 (estimated)
Primary completion10 Dec 2020 (estimated)
Study completion10 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04145999
Sponsor's protocol ID: Erick
Status last verified: Oct 2019
First submitted: 29 Oct 2019
Last updated: 31 Oct 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation: Controlled, Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04145999
Acronym / sponsor ID: Erick
Conditions: Wrinkle
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 96 participants (estimated)
Lead sponsor: University of Nove de JulhoUniversity, hospital or other
Study start: 10 Jan 2020 (estimated)
Primary completion: 10 Dec 2020 (estimated)
Study completion: 10 Dec 2021 (estimated)
First posted: 31 Oct 2019 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PRP + PBM group	Experimental	Procedure: PRP application, Radiation: PhotobiomodulationThis group will receive both PRP application and photobiomodulation.
PRP + placebo PBM	Experimental	Procedure: PRP application, Other: Placebo PhotobiomodulationThis group will receive PRP application and placebo photobiomodulation.
PBM + placebo PRP	Experimental	Other: Placebo PRP application, Radiation: PhotobiomodulationThis group will receive placebo PRP application with a saline solution and active photobiomodulation.

Who may qualify

Ages: 45 to 60 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Menopause (at least 12 months without menstruation);
Healthy;
Skin phototype from I to IV by Fitzpatrick classification.

Key exclusion criteria (7 listed)

History of photosensitivity;
Use of corticosteroids, anticoagulants, or any drug known to increase photosensitivity, including systemic retinoids and topical retinoic acid use for the past 6 months;
Carriers of any collagen-related diseases, malnutrition, anemia, immunosuppression, cancer diseases, smokers, predisposition to hypertrophic and keloid scarring, history of dermatological diseases, facial surgery, facial trauma, conditions that could affect skin condition and psychiatric diseases;
Patients with blood dyscrasias and thrombocytopenia;
Esthetic procedures on the face, such as botulinum toxin application in the last year, facial filling in the last 2 years, chemical peels, ablative laser and dermabrasion in the last year;

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
PRP applicationThe study participant will receive topical anesthesia with lidocaine ointment (50mg/g). After 5 minutes the face will be cleaned with 0.5% alcohol chlorhexidine solution. The newly obtained platelet-rich plasma activated with 10% calcium chloride packed in a 5mL syringe will be applied to the face using a 30G needle in the frontal, lateral periorbital, nasogenian sulcus, bilateral malar region and an infra-auricular point. 0.1ml per cm2 will be injected, totaling 43 points. Only one application of PRP will be performed at the defined points.	Procedure or surgery	PRP + PBM group, PRP + placebo PBM
Placebo PRP applicationBlood collection will be performed normally, the time between collection and application of saline will be the same as the PRP protocol, but in this case, the blood will be discarded, only a sample to quantify the number of platelets will be sent for analysis.	Other	PBM + placebo PRP
PhotobiomodulationPhotobiomodulation will be applied with a Cosmedical LED face mask (São Paulo, Brazil) containing 92 red LEDs. The applications will occur in the experimental periods of 0, 3, 7, 14, 21 and 28 days after the application of PRP or placebo.	Radiation	PBM + placebo PRP, PRP + PBM group
Placebo PhotobiomodulationParticipants will not be aware of whether or not they have received the PBM application as they will be using eye protection and the researcher will position the equipment at the irradiation locations on all participants. The characteristic sound of the device will be triggered by recording in the placebos groups for the PBM. The placebo applications will occur in the experimental periods of 0, 3, 7, 14, 21 and 28 days after the application of PRP.	Other	PRP + placebo PBM

Primary outcome

Change in Photographic Analysis
Time frame: Baseline, 3 months and 6 months after treatment.
Digital photographs of the face obtained before and after 3 and 6 months will be analyzed by 3 plastic surgeons. Each evaluator will receive the same image of wrinkles, all at the end of the experiment. There will be 15 standardized photographs of the face per patient over 6 months of study, totaling 1440 images for each evaluator. Each image should be scored from 0 to 5 using the Wrinkle Assessment Scale.

4 secondary outcomes

Change in Optical Coherence Tomography (OCT) Analysis
Time frame: Baseline, 3 months and 6 months after treatment.
Change in Skin Viscoelasticity
Time frame: Baseline and 3 months after treatment.
Change in Histological Analysis
Time frame: Baseline and 6 months after treatment.
Change of Satisfaction with Facial Appearance
Time frame: Baseline, 3 months and 6 months after treatment.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.

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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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PRP application and Photobiomodulation in people with Wrinkle, run by University of Nove de Julho.

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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Change in Photographic Analysis (time frame: Baseline, 3 months and 6 months 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 NCT04145999.

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 31 Oct 2019.