Evaluation of Intralesional Exosomes Versus Intralesional Saline in The Treatment of Atrophic Scars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- modified Manchester Scar Scale
研究概览
简要总结
Lay Summary (Simple Explanation)
Atrophic scars are depressed scars that form when the skin does not heal properly, commonly seen after acne or injuries. These scars can affect appearance and confidence, and current treatments may not always give satisfactory results.
This study aims to evaluate a new treatment using exosomes, which are tiny particles naturally released by cells that help in skin repair and regeneration. Researchers will compare the effect of injecting exosomes directly into scars versus injecting a simple saltwater solution (saline), which serves as a control.
Participants will be randomly assigned to receive either exosome injections or saline injections. Neither the patient nor the evaluator may know which treatment is given, to ensure fair comparison.
The goal is to determine whether exosomes can safely and effectively improve the appearance and texture of atrophic scars.
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
- Double (Participant, 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
- 否
入选标准
- •Age >18 years
- •Either gender
- •Scars of any duration
- •Multiple scars at one side or both sides of the face.
- •Patients are willing to sign written informed consent statements before beginning treatment.
排除标准
- •Pregnant females.
- •Patients with one scar.
- •Hypersensitivity to any of the used treatments.
- •Patient with infection at the site of the scar.
- •Patients with unrealistic expectations.
- •Patient refusing to sign on the consent.
研究组 & 干预措施
Exosomes
干预措施: Intralesional exosomes (Other)
Saline
干预措施: Intralesional Saline (Other)
结局指标
主要结局
modified Manchester Scar Scale
时间窗: 3 months after 4 biweekly sessions
Scar appearance was assessed using the Modified Manchester Scar Scale. The Modified Manchester Scar Scale ranges from 4 to 24, with lower scores indicating better scar appearance and higher scores indicating worse scar appearance
次要结局
- Scar thickness measurement in millimetres by Ultrasound examination(3 months after 4 biweekly sessions)