A Single-center, Randomized, Split Face Study of the Effects of Micro Needling With Platelet Rich Plasma Compared to Microneedling Without Platelet Rich Plasma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.
研究概览
简要总结
This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device.
详细描述
There have been numerous studies demonstrating benefits of microneedling. However, to date there is no published research expanding on the benefits of using platelet rich plasma in conjunction with microneedling for facial aesthetics. This pilot study will expand knowledge and application of 2 X concentration of Platelet Rich Plasma (PRP) in conjunction with microneedling using the SkinPen device. The pilot aims to objectively measure skin quality using the Visia systemTM and provide objective data to compare Microneedling with the use of (PRP) versus microneedling without the use of PRP. The pilot also aims to subjectively measure skin improvement using the Face QTM and the Global Aesthetic Improvement ScaleTM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males and females ages 30-60 years old.
- •No previous minimally invasive or invasive skin resurfacing within the prior 12 months (i.e. fractionated laser, ablated laser, chemical peels, microneedling, etc...
- •VisiaTM Scan showing aging including skin texture, wrinkles, brown spots, and pores.
- •Patient willing to sign informed consent.
排除标准
- •Keloid scars;
- •History of eczema in treatment area; psoriasis and any other chronic skin conditions the Investigator determines disqualifies the patient for participation in treatment area;
- •History of actinic (solar) keratosis in treatment area;
- •History of hemophilia;
- •History of diabetes;
- •The presence of raised moles, warts on the targeted area.
- •Absolute contraindications include; scleroderma, collagen vascular diseases or cardiac abnormalities; blood clotting problems; active bacterial or fungal infection; facial melanosis; malignant tumors, immunosuppression; use of blood thinners or prednisone; pregnant or nursing women; corticosteroids within two weeks of the procedure, chronic liver disease, porphyria or other skin diseases.
- •Patient not willing to sign informed consent.
结局指标
主要结局
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Skin.
时间窗: 6 months
The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Overall Patient satisfaction of skin improvement assessed by the Global Aesthetic Improvement Scale.
时间窗: 6 months
The Global Aesthetic Improvement Scale (GAIS) is a 5-point scale rating global aesthetic improvement in appearance, compared to pretreatment, as judged by the investigator.
Overall Patient satisfaction of skin improvement assessed by the Face-Q Aesthetic Satisfaction with Outcome.
时间窗: 6 months
The FACE-Q© is a patient-reported outcome (PRO) measure that can be used to measure outcomes of. aesthetic facial procedures and products from the patient's perspective.
Overall Skin improvement assessed by a Visia Scan.
时间窗: 6 months
The VISIA® facial scan uses 3-D imaging to accurately identify and quantify all aesthetic skin concerns, even before there are visible signs of damage or aging. Using a state-of-the-art, multi-point positioning system the visia scanner captures multiple angles of your skin.
次要结局
未报告次要终点