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

NCT04145999 | Unknown Phase 2

• 1 other identifier: Erick
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 3 months and 6 months after treatment.

Secondary Outcomes (4)

• Change in Optical Coherence Tomography (OCT) Analysis

  Baseline, 3 months and 6 months after treatment.

• Change in Skin Viscoelasticity

  Baseline and 3 months after treatment.

• Change in Histological Analysis

  Baseline and 6 months after treatment.

• Change of Satisfaction with Facial Appearance

  Baseline, 3 months and 6 months after treatment.

Study Arms (3)

PRP + PBM group

EXPERIMENTAL

This group will receive both PRP application and photobiomodulation.

Procedure: PRP application; Radiation: Photobiomodulation

PRP + placebo PBM

EXPERIMENTAL

This group will receive PRP application and placebo photobiomodulation.

Procedure: PRP application; Other: Placebo Photobiomodulation

PBM + placebo PRP

EXPERIMENTAL

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

Other: Placebo PRP application; Radiation: Photobiomodulation

Interventions

PRP application 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.

PRP + PBM group; PRP + placebo PBM

Placebo PRP application 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.

PBM + placebo PRP

Photobiomodulation 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.

PBM + placebo PRP; PRP + PBM group

Placebo Photobiomodulation 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.

PRP + placebo PBM

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: January 10, 2020
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2021
• Last Updated: October 31, 2019

Record last verified: 2019-10