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临床试验/NCT03228693
NCT03228693已完成不适用

Gene Expression and Biomarker Profiling of Keloid Skin

Northwestern University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年9月11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
48
试验地点
2
主要终点
Keloid progression

研究概览

简要总结

This study aims to examine both the genetic profile and the biomarkers implicated in keloid scar formation.

Hypothesis:

  1. Differences in the genetic profiles of lesional and non-lesional skin contribute a given population's propensity to develop keloids
  2. Differences in biomolecules expressed in subjects with and without keloids can help predict keloid occurrence and severity
  3. Biomarker analysis will provide useful insights for future targeted therapies for keloid scars

详细描述

Objectives:

  1. Determine gene expression profiles of keloid scar tissue using samples collected longitudinally
  2. Define and compare the molecular biomarkers of keloid scars in keloid (lesional) and non-lesional skin biopsies and serum samples from adult subjects

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
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

  • Patient with an untreated keloid scar or a patient with a keloid scar that has not had treatment for at least 6 months before time of enrollment
  • Patients without keloids coming into the dermatology clinic for a keloid unrelated issue (Group 5 only)

排除标准

  • Patients who have had treatment of their keloid scar within 6 months of date of enrollment

结局指标

主要结局

Keloid progression

时间窗: One year

Assess effectiveness of triamcinolone injection (keloid size measured in millimeters)

Gene Expression

时间窗: One year

Blood will be drawn during first study visit for analysis

Keloid recurrence

时间窗: One year

Assess keloid recurrence at biopsy site (measured by number of keloids)

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

Roopal Kundu

Associate Professor of Dermatology and Medical Education

Northwestern University

研究点 (2)

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