聚左旋乳酸治疗萎缩性痤疮瘢痕
聚左旋乳酸：注射与线雕递送方式在萎缩性痤疮疤痕中的对比研究
Background: Management of atrophic acne scars remains challenging due to their heterogeneous morphology and suboptimal response to conventional therapies. Poly-L-lactic acid (PLLA), a biostimulatory agent, promotes neocollagenesis and has emerged as a promising therapeutic option. However, comparative data on different delivery modalities of PLLA and their effects on dermal remodeling and skin physiology remain limited.
Objective: To compare two delivery modalities of PLLA (injectable versus mono-thread) and evaluate their effects on dermal remodeling, clinical outcomes, and safety in atrophic acne scars.
Methods: This prospective split-face study included 24 patients with atrophic acne scars. The right facial side was treated with a single session of PLLA mono-threads, while the left side received two sessions of injectable PLLA at 6-week intervals. Clinical outcomes were assessed using Goodman and Baron's qualitative and quantitative grading systems over a 3-month follow-up period.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Reham Essam, MD
- 电话号码：+201097709477
- 邮箱：rereessam22@gmail.com
学习地点
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Sharqia Province
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Zagazig、Sharqia Province、埃及、2543
- 招聘中
- Zagazig University Hospitals
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接触：
- Reham Essam
- 电话号码：01097709477
- 邮箱：rereessam22@gmail.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- included adult patients (≥18 years) of both sexes presenting with clinically diagnosed atrophic acne scars (Grades 2-4 according to the Goodman and Baron classification)
Exclusion Criteria:
- active acne lesions, pregnancy or lactation, bleeding disorders, keloid tendency, systemic diseases affecting wound healing, recent acne scar treatment within the past six months, and known hypersensitivity to PLLA components.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：可注射聚左旋乳酸
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The vial was reconstituted with 8 mL of bacteriostatic sterile water for injection (BSWFI). After at least 2 hours, 2 mL of lidocaine (1-2%) with epinephrine was added, making the total solution volume 10 mL. One hour later, the vial was gently shaken, and the syringes were prepared for injection. The injection was given using 28-G needles beneath each scar with a serial injection technique during each session. |
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实验性的：PLLA 线
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On the right side of the face, PLLA threads were used in a single session. Approximately 8-10 Everline PLLA mono-threads |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Goodman和Baron定性分级评分的改变
大体时间：6个月
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6个月
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- ZU-IRB# 212/March 2024
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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