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临床试验/NCT04795310
NCT04795310已完成不适用

A Clinical Observation on the Efficacy and Safety of Pulsed Dye Laser and Intense Pulsed Light With Different Wavelength Bands in the Treatment of Facial Telangiectasia: a Retrospective, Self-controlled Trial

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月1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
150
试验地点
1
主要终点
Severity index of facial telangiectasia

研究概览

简要总结

  1. Facial telangiectasia is one of the common skin vascular lesions characterized by dilated cutaneous vasculatures in the skin surface or mucous membranes. Lesions are generally sensitive to exposure of cold, heat and sun. Those distinct small dilated blood vessels are cosmetically disfiguring for patients which require an effective solution. The traditional management options for facial telangiectasia include cryotherapy, CO2 laser, topical agent, oral estrogens, electrosurgery, and radioactive treatment. However, inadequate outcomes and severe adversaries are the major concerns to patients and physicians.
  2. Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis.

The intense pulsed light source is an alternative or supplement to the already existing laser devices that are part of the laser surgeon's repertoire. The broad wavelength spectrum and variable pulse duration allow greater penetration depths to be reached without damaging surrounding tissue and thus enhance the versatility of this system. 3. This study aims to compare the clearance efficacy of facial telangiectasia using PDL (595nm) with IPL configured by various wavelength bands, including M22 vascular filter (530-650nm and 900-1200nm), M22 560 (560-1200nm), M22 590 (590-1200nm) .

详细描述

Detailed Description has not been entered.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Subjects must be clinically diagnosed with facial telangiectasia
  • No other external treatment was performed before the injury was treated

排除标准

  • subjects with a recent history of exposure to sunlight
  • subjects allergic to topical anesthesia
  • subjects with scar constitution
  • subjects with skin malignant tumors or precancerous lesions
  • subjects with diabetes, heart disease, epilepsy, connective tissue disease, etc
  • subjects who Pregnant or breast feeding
  • subjects with recent skin infections (such as viruses, bacteria, etc.)
  • other methods are being used to treat subjects with similar diseases
  • subject who have taken isotretinoin A in the past year
  • subject with facial dermatitis

结局指标

主要结局

Severity index of facial telangiectasia

时间窗: 6months

1. minimal, focal visible telangiectasia in 5-10% of anatomic area 2. focal visible telangiectasia in11-20% of an anatomic area 3. focal visible telangiectasia in 21-30% of anatomic area 4. visible telangiectasia in 31-40% of anatomic area 5. visible telangiectasia in 41-50% of anatomic area 6. moderately severe telangiectasia in 51-60% of anatomic area 7. moderately severe telangiectasia in 61-70% of anatomic area 8. severe telangiectasia in 71-80% of anatomic area 9. severe telangiectasia in 81-90% of anatomic area 10. severe and diffuse facial telangiectasia in entire anatomic area for facial telangiectasia

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
Principal Investigator
主要研究者

Gang Wang

Chief of Dermatology

Xijing Hospital

研究点 (1)

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