Association of Photobiomodulation With Platelet Rich Plasma Intradermal Injection for Facial Rejuvenation: Controlled, Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 96
- 主要终点
- Change in Photographic Analysis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menopause (at least 12 months without menstruation);
- •Skin phototype from I to IV by Fitzpatrick classification.
排除标准
- •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.
研究组 & 干预措施
PRP + PBM group
This group will receive both PRP application and photobiomodulation.
干预措施: PRP application (Procedure)
PRP + PBM group
This group will receive both PRP application and photobiomodulation.
干预措施: Photobiomodulation (Radiation)
PRP + placebo PBM
This group will receive PRP application and placebo photobiomodulation.
干预措施: PRP application (Procedure)
PRP + placebo PBM
This group will receive PRP application and placebo photobiomodulation.
干预措施: Placebo Photobiomodulation (Other)
PBM + placebo PRP
This group will receive placebo PRP application with a saline solution and active photobiomodulation.
干预措施: Placebo PRP application (Other)
PBM + placebo PRP
This group will receive placebo PRP application with a saline solution and active photobiomodulation.
干预措施: Photobiomodulation (Radiation)
结局指标
主要结局
Change in Photographic Analysis
时间窗: 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.
次要结局
- Change in Skin Viscoelasticity(Baseline and 3 months after treatment.)
- Change in Optical Coherence Tomography (OCT) Analysis(Baseline, 3 months and 6 months after treatment.)
- Change of Satisfaction with Facial Appearance(Baseline, 3 months and 6 months after treatment.)
- Change in Histological Analysis(Baseline and 6 months after treatment.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho