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临床试验/NCT04065217
NCT04065217已完成不适用

Diode Laser 980-nm in Hemangioma Treatment

Noor Taha Ismaeel2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2018年10月14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
发起方
入组人数
15
试验地点
2
主要终点
Area of Hemangioma lesions

研究概览

简要总结

In an academic, government clinic, uni-center, randomized within patients trial study of the effects of 980-nm diode laser treatment included 15 cases of facial hemangiomas in patients with a history of discomfort due to lesions that were not suitable for removal using traditional methods. The study was carried out at the University of Baghdad/Institute of Laser for Postgraduate Studies/Laser Medicine Research Clinics from 15 October 2018 to 15 April 2019. Primary end-point is improvement of conditions at 6 months. Secondary end-points are quality of life, disappear lesions and safety administration of diode laser. Each patient received 12 sessions at two-week intervals. Lesions were photographed before and after laser treatment and digital image histograms were generated as a graphical representation of the tonal distribution.

Following treatment, the lesions were less elevated, smoother in texture, and the color changed from dark red to light pink.

There is a need to improve the treatment of face hemangiomas. Results from this randomized within patient trial will serve as preliminary evidence of the future role of diode laser in hemangioma treatment and a basis for design and power estimations of future studies. Based on the skin texture, color and elevation of the hemangioma as well as patient satisfaction, this type of laser is a safe and effective modality for the treatment of facial hemangioma in Iraqi patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Comfortable.
  • Superficial lesion.

排除标准

  • Advanced case.
  • Deep lesion.
  • Uncomfortable.

研究组 & 干预措施

Iraqi patients with face hemangioma

Other

Diode laser 980-nm in the diseased group only while we no need the comparator group because we compared between lesion before and after. The administration of laser is scheduled to start treatment. Patients will take laser therapy as a 12 session at two week-interval. In case of intolerance, session number reduction by 10, 8, 6, 4 allowed. Adherence to treatment will be assessed at each interval for undesired side effects or complications. The intervention should continue also after complete session, or during temporary interval withdrawal due to reached maximal cumulative response or side effects from laser therapy.

干预措施: Diode laser 980-nm (Procedure)

结局指标

主要结局

Area of Hemangioma lesions

时间窗: 4th week

Measured area of lesions by tape measure by centimeters

Shape of lesion

时间窗: 4 weeks

Clinical exam by inspection, we look to ugly shape of lesion, may be change for better or disappear

Color of lesion

时间窗: 4 weeks

By inspection color of lesion change from dark red to bright red or disappear

次要结局

未报告次要终点

研究者

发起方
Noor Taha Ismaeel
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Noor Taha Ismaeel

Assistant Lecturer

University of Baghdad

研究点 (2)

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