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临床试验/NCT03972566
NCT03972566Unknown不适用

Localized Effects of Photobiomodulation and Exogenous Nitric Oxide on CREST Patients Calcinosis Cutis & Raynaud Phenomenon

RoseLab Skin Optics Laboratory1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2019年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
5
试验地点
1
主要终点
Chemiluminescence detection

研究概览

简要总结

Background CREST is an acronym for the cardinal clinical features of the syndrome (Calcinosis, Raynaud phenomenon, Esophageal dysmotility, Sclerodactyly, and Telangiectasia) and part of the heterogeneous group of sclerodermas.

Calcinosis is the pathologic calcification of soft tissues. When symptomatic, they can be tender and painful, ulcerate, and drain a white chalky substance. With time, heterotopic bone formation may occur. Inflammatory reactions also intermittently occur at the site of calcinosis. It has been suggested that TGF-beta3 plays a major role in the pathogenesis of calcinosis.

A variety of medical therapies have been used to try to alleviate patient symptoms. These include pharmacological approaches (e..g., warfarin), surgical curettage or excision, as well as carbon dioxide laser treatments. No consistently reliable pharmacological treatment seems to be available to prevent or eliminate calcinosis. Curettage and excision and carbon dioxide laser of localized painful large deposits can relieve symptoms but recurrence is common. In addition, aggressive curettage or excision can damage deeper neurovascular structures. While calcinosis is associated with significant morbidity its treatment remains a challenge.

Photobiomodulation (PBM) has been shown to promote wound healing, suppress inflammatory reactions and regulate collagen synthesis in a number of in vitro and in vivo studies.

Human skin contains photolabile nitric oxide (NO) derivatives which decompose after UVA irradiation and release vasoactive NO. However, aside from blue light, barely nothing has been reported about the effects of red and NIR wavelengths.

Method A custom-built air tight sleeve which envelopes the forearm of a subject will be used to measure the NO emanating from the skin under photobiomodulation conditions (red & NIR) and quantified by chemiluminescence detection.

Simultaneously, CREST patient's hands exhibiting calcinosis and/or Raynaud phenomenon will be exposed to exogenous gaseous nitric oxide (INOMAX) to determine the vascular impact of this approach.

This case series will assess Light Emitting Diode (LED) based PBM therapy as a treatment alternative for cutaneous calcinosis and the effects of gaseous NO on calcinosis and/or Raynaud phenomenon in CREST patients.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Male or female
  • 18-60 years of age
  • CREST syndrome with calcinosis cutis.
  • CREST syndrome without calcinosis cutis.

排除标准

  • Diabetes mellitus
  • Acute inflammation
  • Arrhythmia
  • Acute malignancy
  • Renal failure
  • Active CVD
  • Photodermatosis and/or photosensitivity including skin cancer-prone disease/syndrome (XP and Bloom Syndrome)
  • Porphyria and/or hypersensitivity to porphyrins
  • Congenital or acquired immunodeficiency.

研究组 & 干预措施

CREST with Calcinosis cutis

干预措施: INOMAX (Drug)

CREST without Calcinosis cutis

干预措施: INOMAX (Drug)

结局指标

主要结局

Chemiluminescence detection

时间窗: 15 minutes

Sievers Nitric Oxide Analyzer NOA 280i detects \[NO\] in Ambient Air or Solution

Endothelial Measurement

时间窗: 5 minutes

VENDYS II

次要结局

未报告次要终点

研究者

发起方
RoseLab Skin Optics Laboratory
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Daniel Barolet

Director

RoseLab Skin Optics Laboratory

研究点 (1)

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