The Effect of Platelet-rich Fibrin Matrix on Skin Rejuvenation: A Split Face Comparison
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in VISIA skin score
研究概览
简要总结
Platelet-rich fibrin matrix (PRFM) is made from platelets that are extracted from a patient's blood, and many plastic surgeons and dermatologists have used it to fill in wrinkles and lines on the face. Both patients and doctors have observed that it gives extra volume in these areas and improves overall appearance. However, there is no research that shows how PRFM affects skin quality, such as pores, spots, red areas, and texture. The aim of this study is to determine whether PRFM has a role in rejuvenating facial skin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18 years of age and older who had a dermatological concern, specifically, conspicuous spots, pores, rhytids, uneven texture, or red or brown discoloration, and a VISIA complexion analysis score greater than 10
- •Agreed to continue any contraceptive hormonal therapy for duration of the study
- •Agreed to not initiate the use of hormonal therapy during the study
- •Agreed to not undergo any facial procedures or treatments, including injections and fillers, lasers, peels, and topical therapies, during the duration of the study
- •Agreed to adhere to a standardized skin care regimen throughout the duration of the study consisting of the use of a single cleanser and moisturizer twice a day
- •Agreed to refrain from excessive sun exposure/tanning
排除标准
- •History of skin/connective tissue disorders
- •History of immunosuppressive therapy or radiotherapy
- •Participation in facial procedures, such as injections, lasers, peels, and dermabrasion, in the last six months
- •Use of topical/prescription acne medications in the last three months
- •Current smokers or prior smokers who quit fewer than 10 years ago
研究组 & 干预措施
PRFM
Hemi-face injected with PRFM. PRFM was produced from 9 mL of blood (Healeon Medical, Inc).
干预措施: PRFM injection (Procedure)
Saline
Hemi-face injected with saline.
干预措施: Saline injection (Procedure)
结局指标
主要结局
Change in VISIA skin score
时间窗: Skin analysis performed at initial visit, at 6 weeks, and at 12 weeks following initial treatment
Difference between pre- and post-treatment VISIA analysis scores for skin parameters of spots, wrinkles, texture, and pores
次要结局
- Change in Wrinkle Severity Rating Scale(Rating occurred at initial visit, at 6 weeks, and at 12 weeks following initial treatment)
- Skin Rejuvenation Outcomes Evaluation (SROE)(Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.)
- VISIA Outcomes Questionnaire(Evaluation distributed at initial visit, at 6 weeks, and at 12 weeks following treatment.)
研究者
Manoj Abraham
Assistant Professor
New York Medical College