A Comparative Study of the Efficacy of Intralesional Sodium Thiosulfate Versus Intralesional Normal Saline for the Treatment of Dystrophic and Idiopathic Calcinosis Cutis, A Double-Blind Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) for Pain
研究概览
简要总结
The purpose of our research is to compare the effectiveness of 125mg/50ml sodium thiosulfate (STS) solution to normal saline (0.9% sodium chloride) when injected intralesionally for the treatment of calcinosis cutis. Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.
详细描述
Our specific aim is to assess the response of dystrophic and idiopathic calcinosis cutis to the injections of sodium thiosulfate in our patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female adult 18 years of age or older
- •Must have health insurance will be eligible to participate
- •Must have a current diagnosis of dystrophic or idiopathic calcinosis cutis
- •Subjects must have at least 2 lesions of at least 2mm in size
排除标准
- •Unable to read and speak English
- •Allergy to any component of the sodium thiosulfate solution
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Women who are breastfeeding
- •Prisoners
研究组 & 干预措施
Sodium thiosulfate
50 ml vials of sodium thiosulfate (250mg/ml) will be used for treatment.
干预措施: Sodium Thiosulfate (Drug)
Saline solution
30 ml vials of sodium chloride 0.9% will be used for the control treatment.
干预措施: Saline Solution (Other)
结局指标
主要结局
Visual Analog Scale (VAS) for Pain
时间窗: 3 months
The VAS for pain is used to assess the pain associated with the lesion. The pain will be recorded as a number from 1 (no pain) to 10 (severe pain).
Physician Global Assessment (PGA)
时间窗: 3 months
The PGA will be done by the physician to assess appearance and changes in the lesion. The lesion will be assigned a score from 0 (clear) to 4 (severe).
Lesion Size
时间窗: 3 months
The lesion size is measured in square centimeters.
次要结局
未报告次要终点
研究者
David Weinstein
Assistant Professor of Dermatology
University of Central Florida