Evaluation of Microinjected Amnion-derived Collagen by Dermapen in the Smoothing of Skin Wrinkles
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)
研究概览
简要总结
The aim of this work was to assess the efficacy of irradiated amniotic collagen matrix in comparison with platelet rich plasma in facial rejuvenation.The present study included 20 patients with facial wrinkles divided into 2 groups using split face technique: Group (A) subjected to microneedling with amnion gel on the right side of the face . Group (B) subjected to microneedling with PRP on the other side of the face.According to a skin analysis camera (antera camera), there was statistically significant improvement after treatment and between both groups as regard to the roughness(texture) and melanin appeared by Antera camera in which group (A) showed better improvement than group (B). Also, skin biopsies showed improvement in both sides after treatment in which the epidermis was thicker, collagen bundles were broader and thicker than before treatment also elastic fibers were longer, evenly arranged and thicker than before treatment. The patients were followed up over a period of 3 months after the last session with no complications or changes were occurred and the results of sessions were maintained.
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
- Single (Investigator)
入排标准
- 年龄范围
- 36 Years 至 57 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who did not receive any treatment for aging within the last 6 months.
- •Patients who accepted to participate in this study.
排除标准
- •Patients with bleeding, coagulation disorders, severe anemia, liver disease, renal disease, recurrent facial herpes, keloid formation, pregnant, and lactating females.
结局指标
主要结局
Evaluation of facial wrinkles according to wrinkle severity rate scale (WSRS)
时间窗: 2 weeks
grade 0 = no wrinkles, grade I = just perceptible wrinkle, grade II = shallow wrinkles, grade III = moderately deep wrinkles, grade IV = deep wrinkle with well-defined edges, grade V = very deep wrinkle with redundant fold.
skin pigmentation assessed by skin hyper-pigmentation index
时间窗: 2 weeks
score: No pigmentation=1, sever pigmentation=4
Evaluation of facial wrinkles according to Global Aesthetic Improvement Scale (GAIS)
时间窗: 2 weeks
No improvement or mild improvement less than 25% moderate improvement = 26%-50% marked improvement = 51%-75% excellent improvement = more than 75%
Histopathology improvement of skin biopsy
时间窗: 2 weeks
improved skin structure=1, non-improved skin structure=0
次要结局
未报告次要终点
研究者
Nashwa Radwan
Head of amnion preparation laboratory
Egyptian Atomic Energy Authority