The Combination Therapy of Fractional Laser and Platelet-Rich Plasma Injection Compared With Nanofat Grafting and Platelet-Rich Plasma Synergy in Treating Striae Gravidarum.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Immunohistochemical analysis
研究概览
简要总结
Nowadays, multiple treatment modalities have been applied clinically to treat striae gravidarum, such as laser therapy, microdermabrasion, platelet-rich plasma injection(PRP), etc. To some extent, these treatments can improve striae gravidarum. In this clinical trial, the investigators are going to treat striae gravidarum by using two different kinds of combination therapies. One is fractional laser and PRP injection synergy, and the other one is treated by nanofat grafting with PRP injection.
详细描述
The investigators will pick out two areas of most severe striae gravidarum on a participant's abdomen. One of the areas will be treated by fractional laser once every three months for 2 times combined with PRP injection once a month for 6 times. Another area will be treated by nanofat grafting once every three months for 2 times and PRP therapy once a month for 6 times. The participants were asked to come back 1、3、6、9 months after treatment for further follow-up.
Before and after the treatment, the striae gravidarum will be assessed subjectively by satisfaction assessment, dermatoscope and ultrasound, and objectively by immunohistochemical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The striae gravidarum was appeared within 3 years
- •Age ≤ 35 years old
- •Not in lactation
- •Not pregnancy within one year
排除标准
- •Skin allergy
- •Skin inflammation or wound
- •Platelet dysfunction syndrome
- •Take anticoagulant drugs
- •Acute or chronic infection
- •Chronic liver disease
- •Photodermatosis
- •Active vitiligo, psoriasis, systemic lupus erythematosus
- •Other clinical trial
结局指标
主要结局
Immunohistochemical analysis
时间窗: Baseline and 15 months.
The tissue extracted will be taken for immunohistochemical analysis to observe the change of epidermal and dermal thickness, and the distribution and amount of elastic fiber and collagen fiber,etc.
次要结局
- Ultrasound(Baseline and at 3,6,9,12,15 months after the treatments.)
- Dermatoscope(Baseline and at 3,6,9,12,15 months after the treatments.)
研究者
Li-Ling Xiao
Associate Chief of Department of Plastic Surgery,The First Affiliated Hospital of Jinan University, Guangzhou
First Affiliated Hospital of Jinan University