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临床试验/NCT03460431
NCT03460431已完成不适用

Evaluation of Fractional CO2 and Non Ablative Long Pulsed Nd YAG Lasers Alone and in Combination in Treatment of Keloids

Cairo University0 个研究点目标入组 30 人开始时间: 2014年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
主要终点
comparison between different laser modalities in treatment of keloids clinically

研究概览

简要总结

clinical comparative study comparing the effectiveness of fractional CO2, long pulsed Nd YAG and their combination in collagen remodeling in keloid clinically, biochemically and histopathologically

详细描述

Patients The study included 30 Egyptian patients with keloid scar recruited from the Out Patient Clinic, Dermatology Department, Cairo University.

Methodology

Patients:

  • Thirty patients with keloid scar(s) were included in the study

  • Every patient was subjected to the following:

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
None

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

  • •Patients with keloid scars of at least 6 months duration.
  • •No limitations regarding sex of the patients.
  • •Patients with three or more lesions 2 to 3 cm apart or patients having a large sized lesion.

排除标准

  • •Patients who had received any form of treatment during the last four weeks prior to treatment such as intralesional steroids or a laser procedure during the last six months.
  • •Patients with active skin infections e.g. herpes or autoimmune disease.
  • •Patients with previous history of adverse outcome related to laser therapy.
  • •Recent use of Isotretinoin (within 6 months prior to the procedure).
  • •Patients with known allergies to lidocaine.
  • •Smoking, pregnancy
  • •Patients with unrealistic expectations

研究组 & 干预措施

fractional CO2 laser 10,600nm

Experimental

fractional CO2 laser 10,600nm one session every month for 4 months

干预措施: fractional CO2 laser 10,600nm (Device)

Nd YAG laser 1064nm

Experimental

Nd YAG laser 1064nm

干预措施: Nd YAG laser1064 nm (Device)

combined two laser types

Experimental

combined fractional CO2 laser 10,600nm and Nd YAG laser 1064nm lasers treatment to keloid

干预措施: fractional CO2 laser 10,600nm (Device)

combined two laser types

Experimental

combined fractional CO2 laser 10,600nm and Nd YAG laser 1064nm lasers treatment to keloid

干预措施: Nd YAG laser1064 nm (Device)

结局指标

主要结局

comparison between different laser modalities in treatment of keloids clinically

时间窗: 5 months

assessed by Patient and Observer Scar assessment Scale

comparison between different laser modalities in treatment of keloids morphometrically

时间窗: 5 months

assessed by Quantitative morphometric analysis using Leica Qwin 500 Image Analyzer (LEICA Imaging Systems Ltd, Cambridge, England) measuring area percent of collagen and elastin fibers in micrometer squared

comparison between different laser modalities in treatment of keloids biochemically

时间窗: 5 months

assessed by level of transforming growth factor beta 1 and 3 using Human TGF-B ELISA kit provided by ID labs Biotechnology London, ON, Canada.measurement unit is nano gram per gram tissue

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Foad Mohamed

specialist of dermatology.students hospital. Cairo university

Cairo University

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