NCT01574872撤回2 期
Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Inverse Psoriasis and Sebopsoriasis
Tecno Sun SRL2 个研究点 分布在 1 个国家开始时间: 2012年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Aerosal® compared to placebo in the prognosis of inverse psoriasis or sebopsoriasis present for at least one year
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inverse Psoriasis or Sebopsoriasis lasting from at one year
- •At least 1% of total body surface area involvement Suspension for more than 3 months from start of the study of any systemic drugs for psoriasis, immunosuppressive treatments (cyclosporin, systemic steroids), psoralen plus ultraviolet A irradiation (PUVA) or ultraviolet B phototherapy (UVB)
排除标准
- •Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure
- •Iodine allergy
- •Women who are pregnant or planning to become pregnant during the study
研究组 & 干预措施
Aerosal
Experimental
This arm include all patients treated with Aerosal®
干预措施: Halotherapy (Device)
Placebo
Placebo Comparator
This arm include all patients treated with placebo
干预措施: Placebo (Device)
结局指标
主要结局
Percent change from baseline of PASI index equal to or greater than 50% (PASI50 +)
时间窗: 3 weeks (15 sessions), 15 weeks
次要结局
- Overall patient satisfaction(3 weeks (15 sessions), 15 weeks)
- Any change from baseline of physician's clinical judgment(3 weeks (15 sessions), 15 weeks)
- Number of reported adverse events(3 weeks (15 sessions), 15 weeks)
- Any change from baseline of PASI index(3 weeks (15 sessions), 15 weeks)
研究者
研究点 (2)
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