Efficacy of Intradermal Stromal Vascular Fraction Injection in the Treatment of Atrophic Acne Scar
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 16
- 主要终点
- Change in total number of atrophic acne scars from baseline to Week 5
研究概览
简要总结
This study aims to evaluate the efficacy and safety of intradermal injection of autologous stromal vascular fraction (SVF) in the treatment of atrophic acne scars. SVF is a heterogeneous cell population derived from adipose tissue, containing various regenerative and immunomodulatory cells, including mesenchymal stem cells, endothelial progenitor cells, and pericytes.
In this prospective, randomized, split-face clinical trial, participants with atrophic acne scars will receive SVF injections on one side of the face and normal saline (NS) injections on the contralateral side as a control. Clinical efficacy will be assessed through blinded scar counts, digital imaging, and histological evaluations including epidermal and dermal regenerative markers. The study is designed to investigate whether SVF provides superior clinical improvement compared to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 19 and 45 years
- •Presence of bilateral atrophic acne scars (boxcar, rolling, or icepick types) on the face
- •Willingness to undergo fat harvesting procedure
- •Ability to comply with study visits and follow-up
- •Written informed consent obtained
排除标准
- •Active acne lesions on the treatment area
- •History of keloid or hypertrophic scarring
- •Prior treatment for acne scars (e.g., laser, filler, microneedling) within the past 6 months
- •History of systemic immunosuppressive therapy within the past 3 months
- •Pregnant or breastfeeding women
- •Any systemic disease that may interfere with wound healing or safety assessment (e.g., uncontrolled diabetes, collagen vascular disease)
研究组 & 干预措施
SVF-treated side
Intradermal injection of autologous stromal vascular fraction (SVF) on one side of the face.
干预措施: stromal vascular fraction (SVF) (Biological)
Saline-treated side
Intradermal injection of normal saline (NS) on the contralateral side of the face.
干预措施: Normal Saline (NS) (Other)
结局指标
主要结局
Change in total number of atrophic acne scars from baseline to Week 5
时间窗: Baseline and 5 weeks after treatment
Change in total number of atrophic acne scars from baseline to Week 10
时间窗: Baseline and 10 weeks after treatment
次要结局
未报告次要终点
研究者
Dae Hun Suh
Professor
Seoul National University Hospital