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临床试验/NCT04274842
NCT04274842已完成不适用

Dynamic Optical Coherence Tomography Imaging of Telangiectasia Prior to Intense Pulsed Light Treatment - an Opportunity to Target Treatment?

Zealand University Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
2
主要终点
vessel width dimension

研究概览

简要总结

Objectives: To examine whether dynamic Optical Coherence Tomography (OCT) could characterize vessel dimensions and blood flow of telangiectasias before and after treatment with Intense Pulsed Light (IPL).

Methods: Dynamic-OCT (D-OCT) imaged telangiectasia characterized blood vessel width and depth, blood flow, and attenuation. Measurements were done immediately before and after, 1-3 days after, and 1 month after IPL treatment. Characterization of vessel dimensions at baseline were verified by a blinded observer. At one-month follow-up, clinical improvement was characterized as good, moderate or none and possible adverse effects were described.

详细描述

Introduction Telangiectasia of the face are a common facial cosmetic disorder and may cause severe psychological distress. Facial telangiectasia may be treated with pulsed dye laser (PDL) or intense pulsed light (IPL). Clinical results are not always satisfactory and numerous treatments may be necessary to achieve acceptable results. Unexperienced operators often depend on treatment guidelines provided by the manufacturer when selecting energy settings for treatment, while more experienced operators may be guided by the immediate post-treatment biological endpoints and history of adverse events from previous treatment sessions. Thus, several treatments are often needed to determine optimal energy settings for the individual patient.

In general, light energy must be targeted to individual blood vessel dimensions, when optimizing laser or IPL treatment of vascular lesions. In clinical practice it may however be challenging to decide vessel width, vessel depth and blood flow by merely looking at the skin.

Optical coherence tomography (OCT) is a non-invasive in vivo imaging technique, which provides images of superficial skin structures. It has previously been demonstrated that OCT can visualize facial telangiectasias before and after IPL treatment. Dynamic OCT (D-OCT) adds identification and measurement of superficial cutaneous blood vessels with great certainty. Therefore, the aim of this study was to investigate whether D-OCT could be utilized to characterize vessel dimensions and blood flow of facial telangiectasias before and after IPL treatment.

Material and Methods Patients with telangiectasias visiting the Department of Dermatology for IPL treatment of telangiectasia at the Zealand University Hospital, Roskilde, between February and November 2018 were offered participation after informed consent. The study was approved by the Science Ethics Committee of Region Zealand (Approval no.: SJ-651) and the Danish Data Protection Agency (Approval no.: REG-177-2017).

D-OCT imaging was done immediately before, 1-3 days after, and one month after scheduled IPL treatment. The D-OCT scans and IPL treatments were performed by two separate physicians and the treating physician was blinded to all information obtained by D-OCT.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

入选标准

  • legally competent,
  • at least 18 years of age
  • persons able to read and understand spoken and written information in Danish or English.
  • One or more facial telangiectasia

排除标准

  • wounds or ulcers in area of facial telangiectasia

结局指标

主要结局

vessel width dimension

时间窗: one-month follow-up

measurement of vessel width on D-OCT images

vessel depth dimension

时间窗: one-month follow-up

measurement of vessel depth on D-OCT images

vessel blood flow

时间窗: one-month follow-up

measurement of vessel blood flow on D-OCT images

Attenuation

时间窗: one-month follow-up

measurement of attenuation on D-OCT images

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

Gregor Jemec

Professor, PhD, DmsC, Head of Dpt.

Zealand University Hospital

研究点 (2)

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