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临床试验/NCT03979378
NCT03979378Unknown不适用

Treatment of Ectopic Calcification / Ossification With Sodium Thiosulfate (CATSSO)

University Hospital, Limoges7 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
7
主要终点
Calcification/Ossification volume

研究概览

简要总结

Ectopic calcification and ossification complicate many diseases, which are rare for the most part. These calcifications (or ossifications) are generally classified according to their apparent formation mechanism. Even if very different diseases can be at the origin, these calcifications (or ossifications) have as common points: an unknown physiopathology, a composition of calcium pyrophosphate for the most part and l no curative treatment validated to date.

Indeed, although several reported cases suggest the potential efficacy of different treatments , none of these treatments is currently recognized as effective because of the absence of confirmation data or because of contradictory results.

Sodium thiosulfate (STS) has been used for a long time as an antidote to cyanide poisoning and as a protective agent against cytotoxic side effects such as ifosphamide. More recently, STS has been reported in the treatment of renal calcification. vascular or even subcutaneous. First prospective studies on animal models and in humans seem to confirm the interest of this product in the treatment of these abnormal calcifications.

For several months, a magistral preparation in the form of ointment based on STS has been developed by the pharmacy of Limoges University Hospital in order to combine the local effect of STS while avoiding the side effects of an administration of this treatment by systemic way. The first uses of this preparation appear promising and some preliminary results have already been published. The benefit / risk ratio of this approach seems to be advantageous for clinicians since preparations whose composition is close are currently validated by the FDA and the World Health Organisation for the treatment of benign pathologies such as cutaneous dermatophytes or pityriasis versicolor.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any patient treated with sodium thiosulfate dermally provided by the pharmacy of Limoges University Hospital.
  • availability of an objective imaging evaluation to compare the volume or surface of calcifications (or ossifications) treated (on two orthogonal incidences) before and after 6 months of treatment application.
  • consent to participation in the study signed by the patient or by one of the holders of parental authority in the case of a minor patient.

排除标准

  • calcification with concomitant cutaneous rupture which can allow an externalization of the calcium material by mechanical effects.
  • Patient with calcification secondary to one of the following pathologies:
  • chronic renal failure
  • iatrogenic origin

结局指标

主要结局

Calcification/Ossification volume

时间窗: Month 6

Percentage decrease in the volume or surface area of calcifications (or ossification) treated on imaging of the same type performed before and 6 months after dermal STS use.

次要结局

  • Change in pain from baseline at 6 month(Day 0, Month 6)
  • Change of the quality of life from baseline at 6 month(Day 0, Month 6)
  • local or general side effects(Month 6)
  • Change in aesthetic evolution from baseline at 6 month(Day 0, Month 6)

研究者

发起方
University Hospital, Limoges
申办方类型
Other
责任方
Sponsor

研究点 (7)

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