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临床试验/NCT04722705
NCT04722705Unknown不适用

Efficacy of Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention

Hallym University Kangnam Sacred Heart Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年1月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Patient Observer Scar Assessment Scale

研究概览

简要总结

The scar site was divided into 3 sites; combined IPL/fractional Er:YAG laser treatment site, fractional Er:YAG laser treatment site and untreated control site. At baseline, three lesions were randomized to IPL / fractional Er:YAG laser combination therapy site, fractional Er:YAG laser treatment alone site, and untreated control site. The laser treatment was conducted total three sessions, immediately at suture removal (baseline), 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment (20 weeks after suture removal).

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
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of postoperative scars on the abdomen
  • scars were symmetrical shaped in a line of 3cm or more

排除标准

  • uncontrolled systemic or chronic disease
  • hypersensitive to the ingredients
  • a history of other laser treatments within the past 6 months
  • pregnancy
  • lactation
  • Recent sun exposure

结局指标

主要结局

Patient Observer Scar Assessment Scale

时间窗: 20 weeks

The POSAS observer consists of following 6 items: vascularity, pigmentation, thickness, surface area, relief, pliability. Each item was evaluated on a scale from 1 (normal skin) to 10 (worst scar). Finally, the POSAS total score was calculated as the sum of six items, ranging from 6 to 60.

次要结局

  • Total Vancouver Scar scale(20 weeks)
  • Erythema index(20 weeks)
  • Melanin index(20 weeks)

研究者

发起方
Hallym University Kangnam Sacred Heart Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Young Chung

Principal Investigator, Clinical Professor

Hallym University Kangnam Sacred Heart Hospital

研究点 (2)

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