Low-dose UVA1 Radiation in Cutaneous Lupus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score
研究概览
简要总结
The investigators are conducting an open-label clinical trial determining the effects of UVA1 phototherapy on cutaneous lupus (CLE) patients. Past research on systemic lupus (SLE) subjects indicates that this treatment is likely to be effective in treating cutaneous lupus with few side effects. The fact that most CLE patients are seen at dermatology clinics also increases the usefulness of this study because there is a large probability that phototherapy treatment will be accessible for many of the patients that stand to benefit from it.
详细描述
Study subjects will receive low dose (20 J/cm2) UVA1 phototherapy treatment three times per week for 10 weeks. Each treatment will take less than 30 minutes. This period will be followed by an eight-week observation phase to assess longer term effects of the treatment. Patients will be assessed for disease activity, and blood studies and photos will be completed prior to, during, and after phototherapy treatment. Optional skin biopsies of affected and unaffected skin will be performed at the beginning and end of the active treatment phase.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You must be 18 years or older with a diagnosis of cutaneous lupus.
- •You must have at least two active areas of cutaneous lupus.
- •You will need to come in three days a week for a 10-week period.
- •You will need to participate in four physician visits and blood draws.
排除标准
- •You do not have a diagnosis of cutaneous lupus.
- •You have less than two active areas of cutaneous lupus.
- •You are unable to come in three days a week for treatment for a 10-week period.
结局指标
主要结局
Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Activity Score
时间窗: 10 weeks
The CLASI activity score represents the amount of skin disease activity in cutaneous lupus patients, as evaluated by a provider. The minimum score is 0 (no disease activity), and the maximum score is 70 (maximum/worst disease activity). The change is measured at the start and end of the UVA1 trial therapy.
次要结局
- Change in Cutaneous Lupus Disease Area and Severity Index (CLASI) Damage Score(10 weeks)
研究者
Ben Chong
Associate Professor
University of Texas Southwestern Medical Center