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临床试验/NCT04265599
NCT04265599招募中不适用

Hypercalcemia After Cosmetic Paraffin Oil Injections: Unravelling Etiology, Pathogenesis and Potential Treatments

Herlev Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年4月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia

研究概览

简要总结

The aim of the study is to characterize paraffin oil induced granulomatous disease. We will investigate pathogenesis and natural history of paraffin disease. Subsequently, through further translational studies, we intend to identify novel treatments to be tested in future randomized clinical trials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • previous intramuscular injection of paraffin or other oil

排除标准

  • 未提供

结局指标

主要结局

Number of patients with concentration of ionized calcium in plasma above normal range = Hypercalcemia

时间窗: at first examination or developed during observation period until 2025

Hypercalcemia in plasma (exploratory not intervention study). yes or no and level.

Number of patients with concentration of parathyroid hormone PTH in plasma below normal range

时间窗: at first examination or developed during observation period until 2025

PTH level in plasma indicator of hypercalcemia

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

Ebbe Eldrup, MD, DMSc

Principal investigator Consultant Endocrinologist MD DMSc

Herlev Hospital

研究点 (1)

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