跳至主要内容
临床试验/NCT06116162
NCT06116162已完成不适用

Department of Dermatology of Xijing Hospital of Air Force Medicial University

Xijing Hospital2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
ECCA scale score

研究概览

简要总结

Background Adipose extracellular matrix/stromal vascular fraction gel(SVF-gel), which contains adipose-derived stem cells, endothelial cells, smooth muscle cells, pericytes, and other cell components.

Objective To determine the efficacy and safety of SVF-gel for treating acne scars and to compare the results with CO2 fractional laser.

Methods Seventeen patients with moderate to severe acne scars were treated with SVF-gel filling and CO2 fractional laser through a 24-week, randomized split-face study. One randomly assigned half side of each patient's received one SVF-gel filling treatment and the other side by two CO2 fractional laser treatment once one months. Clinical improvement was assessed by two blinded investigators with Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale, VISIA and Antaro-3D detection.

详细描述

This study was designed as a 24-week, prospective, randomized split-face protocol that compared clinical courses between two facial sides either receiving SVF-gel injection or CO2 fractional laser for acne scars. At the initial presentation, the evaluation of the severity of acne scar by Echelle d'Evaluation Clinique des Cicatrices d'acne (ECCA) scale (Table1), VISIA and Antera 3D analysis for all enrolled patients. Then, each facial side of every patient was randomly assigned into either SVF-gel injection or CO2 fractional laser treatment side. A random allocation sequence was created using computer-based random number generators to assign the treatment modality of each side. Randomization codes were secured in a safe until all data analyses were finished. Each patient was received SVF-gel injection for just one time on one half face, CO2 fractional laser treatment for two consecutive sessions at 8-week intervals on the other half face, with a follow-up visit at 16 weeks after the final CO2 fractional laser treatment. Evaluations of each treatment sessions were performed after 1 week, 2 months of every treatment. Two dermatologists evaluating the severities of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Two dermatologists evaluating the severity of acne scars were blinded to the assignment. At patients' each evaluation visit, photographic assessments by dermatologists, VISIA and Antera 3D analysis and patients' subjective assessments were conducted.

入排标准

年龄范围
16 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Acne scar patients with severity of moderate to severe by ECCA scale evaluation.
  • All the subjects were not allowed to use any systemic, topical, or light-based acne scar treatment during the course of this study.

排除标准

  • pregnancy, mental illness.
  • Intake of oral isotretinoin within 3 months
  • Application of the other chemical peeling and light-based treatments within 8 weeks

结局指标

主要结局

ECCA scale score

时间窗: 3 Month after the second CO2 Fractional Laser treatment

ECCA scale score of each face before and after the treatment of SVF-gel filling and CO2 Fractional Laser

次要结局

未报告次要终点

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验