Phase 2 Multicentric Study Evaluating the Efficacy of Polyvalent Intravenous Immunoglobulins in Idiopathic Severe and Refractory Solar Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
研究概览
简要总结
Solar urticaria is a rare but debilitating disease that can severely impact the quality of life, restricting outdoor activities.Treatment, based on sun protection and anti-histaminic drugs, is efficacious in 2 patients out of 3. In refractory patients, photodesensitization or immunosuppressive treatments such as cyclosporin A can be proposed. As in idiopathic urticaria, intravenous immunoglobulins (IVIG)have been shown, in a retrospective study of 7 patients, to dramatically improve 71% of patients. In an open-label prospective multicenter study, we aim to demonstrate the efficacy of a single IVIG administration (2g/kg) in 10 patients affected with severe and refractory solar urticaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •social insurance
- •signed informed consent
- •solar urticaria (SU) confirmed with photoexplorations
- •SU involving the face or generalized to the whole body or accompanied with bronchospasm or triggered by artificial light or per annual SU
- •SU with altered quality of life
- •SU resistant to photoprotection
- •SU resistant to the association of two different antihistaminics during 3 months
排除标准
- •Pregnancy
- •Heat triggered urticaria
- •Contra-indications to IVIG
研究组 & 干预措施
Intravenous immunoglobulins
Intravenous immunoglobulins
干预措施: Intravenous immunoglobulins (Drug)
结局指标
主要结局
Percentage of patients obtaining 3 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose
时间窗: 3 months
次要结局
- Percentage of patients obtaining 1 month after treatment a 10 fold increase of pretherapeutic minimal urticarial dose(1 month)
- Percentage of patients obtaining 1 month after treatment an improvement of quality of life(1 month)
- Percentage of patients obtaining after 1 month of treatment a complete clinical response(1 month)
- Percentage of patients obtaining 1 month after treatment a 50% and a 75% improvement of disease severity(1 month)
- Percentage of patients obtaining 6 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose(6 months)
- Percentage of patients obtaining 12 months after treatment a 10 fold increase of pretherapeutic minimal urticarial dose(12 months)
- Percentage of patients obtaining 3 months after treatment an improvement of quality of life(3 months)
- Percentage of patients obtaining 6 months after treatment an improvement of quality of life(6 months)
- Percentage of patients obtaining 12 months after treatment an improvement of quality of life(12 months)
- Percentage of patients obtaining after 3 months of treatment a complete clinical response(3 months)
- Percentage of patients obtaining after 6 months of treatment a complete clinical response(6 months)
- Percentage of patients obtaining after 12 months of treatment a complete clinical response(12 months)
- Percentage of patients obtaining 3 months after treatment a 50% and a 75% improvement of disease severity(3 months)
- Percentage of patients obtaining 6 months after treatment a 50% and a 75% improvement of disease severity(6 months)
- Percentage of patients obtaining 12 months after treatment a 50% and a 75% improvement of disease severity(12 months)