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

Phase 2

• Conditions: Wrinkle
• Interventions: Procedure: PRP application; Other: Placebo PRP application; Radiation: Photobiomodulation; Other: Placebo Photobiomodulation

• Registration Number: NCT04145999
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-29
• Study First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Study First Posted: 2019-10-31
• Last Update Posted: 2019-10-31
• Study Start: 2020-01-10
• Primary Completion: 2020-12-10
• Study Completion: 2021-12-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PBM + placebo PRP	Photobiomodulation	This group will receive placebo PRP application with a saline solution and active photobiomodulation.
PRP + placebo PBM	PRP application	This group will receive PRP application and placebo photobiomodulation.
PRP + PBM group	Photobiomodulation	This group will receive both PRP application and photobiomodulation.
PRP + PBM group	PRP application	This group will receive both PRP application and photobiomodulation.
PBM + placebo PRP	Placebo PRP application	This group will receive placebo PRP application with a saline solution and active photobiomodulation.
PRP + placebo PBM	Placebo Photobiomodulation	This group will receive PRP application and placebo photobiomodulation.

Primary Outcome Measures

Name	Time	Method
Change in Photographic Analysis	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.

Secondary Outcome Measures

Name	Time	Method
Change in Skin Viscoelasticity	Baseline and 3 months after treatment.	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.
Change in Optical Coherence Tomography (OCT) Analysis	Baseline, 3 months and 6 months after treatment.	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.
Change of Satisfaction with Facial Appearance	Baseline, 3 months and 6 months after treatment.	Participants will answer the FACE-Q questionnaire, that ranks Satisfaction with Facial Appearance.
Change in Histological Analysis	Baseline and 6 months after treatment.	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.