Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
研究概览
简要总结
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. The usefulness of immunosuppressive drugs have suggested by uncontrolled study.
In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks.
This study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.
详细描述
Pre-inclusion stage: Case history, clinical examination, laboratory study, inclusion criteria checking.
Inclusion stage: Inclusion and exclusion criteria checking, clinical examination, disease follow-up, written inform consent.
Ambulatory hospitalisation, laboratory study.
Treatment and follow-up of the patients.
Clobetasol propionate cream application and leflunomide introduction.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 65 years old
- •Bullous pemphigoid :
- •Newly diagnosed bullous pemphigoid : No treatment or topical corticosteroids therapy for less than one month
- •BP diagnosed : Resistance of the BP to the treatment or recurrence 6 months at least after diagnosis
- •Follow up monthly during one year accepted
- •Written Inform Consent
排除标准
- 未提供
结局指标
主要结局
Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
次要结局
- To determine the rate of clinical complete remission at M9 and M12.
- To estimate the number of patients with immunological remission at M6, M9 and M12.
- To evaluate monthly the tolerance of leflunomide.