NCT00625521已完成2 期
Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety profile, CLASI score, GIA and GPA.
研究概览
简要总结
Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.
The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of either DLE or SLE
- •Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)
- •Is prepared to grant authorised persons access to the medical records
- •Has signed informed consent
排除标准
- •Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome
- •Has scarring at the target lesion
- •Systemic treatment of SLE
研究组 & 干预措施
1
Experimental
Drug: ASF 1096 0.5 % cream applied twice daily
干预措施: ASF 1096 0.5 % cream applied twice daily (Drug)
2
Placebo Comparator
Cream vehicle for ASF 1096 cream applied twice daily
干预措施: Cream vehicle for ASF 1096 cream applied twice daily (Drug)
结局指标
主要结局
Safety profile, CLASI score, GIA and GPA.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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