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

NCT ID: NCT04145999

Last Updated: 2019-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2021-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Wrinkle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
A single researcher will perform the treatment and he/she will not perform any evaluation. Pre- and post-treatment evaluations will be made by four examiners (three plastic surgeons and one pathologist) who will not be aware of the group to which each patient will be allocated. Participants will not be aware of whether or not they have received the PRP, the application syringes will be camouflaged with opaque adhesive on the outside and they will not be aware whether or not they have received the PBM application as they will be using eye protection and the person who applies it will position the equipment at the irradiation sites on all participants and will only turn on the light in the specific experimental group. The characteristic sound of the device will be triggered by recording in the placebo groups for the PBM.

Study Groups

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PRP + PBM group

This group will receive both PRP application and photobiomodulation.

Group Type EXPERIMENTAL

PRP application

Intervention Type PROCEDURE

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.

Photobiomodulation

Intervention Type RADIATION

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.

PRP + placebo PBM

This group will receive PRP application and placebo photobiomodulation.

Group Type EXPERIMENTAL

PRP application

Intervention Type PROCEDURE

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 Photobiomodulation

Intervention Type OTHER

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.

PBM + placebo PRP

This group will receive placebo PRP application with a saline solution and active photobiomodulation.

Group Type EXPERIMENTAL

Placebo PRP application

Intervention Type OTHER

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.

Photobiomodulation

Intervention Type RADIATION

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.

Interventions

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PRP application

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.

Intervention Type PROCEDURE

Placebo PRP application

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.

Intervention Type OTHER

Photobiomodulation

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.

Intervention Type RADIATION

Placebo Photobiomodulation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Sandra Kalil Bussadori

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Erick

Identifier Type: -

Identifier Source: org_study_id