Efficacy of Intense Pulsed Light (IPL) in the Treatment of Facial Telangiectasia in Patients With Systemic Lupus Erythematosus (SLE): a Randomized, Evaluator-blinded, Split-face Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of Five-Point Telangiectasia Scale after three times of IPL treatment
研究概览
简要总结
This clinical trial intends to evaluate the efficacy and safety of intense pulsed light (IPL) in the treatment of facial telangiectasia in patients with systemic lupus erythematosus (SLE).
详细描述
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can involve multiple organs and systems. The treatment for SLE mainly depends on long-term use of glucocorticoids. For many patients with SLE, facial telangiectasia is a commonly seen side effect of long-term use of glucocorticoids. Featured by facial erythema with or without flushing or burning sensation, facial telangiectasia seriously affects the quality of life of patients. However, up to now, there has been little attention paid to this condition in SLE patients. There have been a lack of effective treatment options for tackling this problem.
Intense pulsed light (IPL) is a non-laser light source used to treat a variety of vascular and pigmented lesions. Unlike ultraviolet that is harmful to patients with SLE, application of IPL may be a safe and effective treatment for SLE patients with facial telangiectasia. This study intends to evaluate the efficacy and safety of IPL in the treatment of facial telangiectasia for SLE patients that has been treated with long-term corticosteroids.
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
- Single (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
- •Age: between 18 and 65 years;
- •Patients definitedly diagnosed with systemic lupus erythematosus according to "Diagnostic Criteria for systemic lupus erythematosus";
- •Patients receiving continuous treatment of glucocorticoid in the last 4 weeks.
排除标准
- •Patients with severe diseases of heart, brain, lungs, liver, kidney, or blood system;
- •Patients with drug abuse, alcohol abuse, or mental disorders that are unable to cooperate or adhere to treatment;
- •Pregnant women, lactating women or women who are ready to conceive within 6 months;
- •Participated in other clinical trials within 3 months before the screening.
结局指标
主要结局
Change of Five-Point Telangiectasia Scale after three times of IPL treatment
时间窗: 12 weeks
Five-Point Telangiectasia Scale will be used to assess improvement of telangiectasia and erythema. The range of TGS is 1 to 5, where 1 means less than 5% clearance, 2 means 5-25% clearance, 3 means 25-50% clearance, 4 means 50-75% clearance, and 5 means 75-100% clearance, compared to baseline before IPL treatment.
次要结局
- Change of Five-Point Telangiectasia Scale after 4, 8, and 24 weeks, respectively.(4, 8, and 24 weeks)
- Change of Clinician's Erythema Assessment (CEA) scores after a 4-, 8-, 12- and 24-week treatment, respectively.(4, 8, 12, and 24 weeks)
- Change of Patient Global Assessment (PGA) after a 4-, 8-, 12- and 24-week treatment, respectively.(4, 8, 12, and 24 weeks)
- Change of Dermatology Life Quality Index (DLQI) scores after a 4-, 8-, 12-, and 24-week of treatment, respectively.(4, 8, 12, and 24 weeks)
- Change of Skindex-16 scores after a 4-, 8-, 12- and 24-week of treatment, respectively.(4, 8, 12, and 24 weeks)
- The safety evaluation about the adverse reactions throughout the entire study process.(4, 8, 12, 16, and 36 weeks)
- Change of SLEDAI scores after 12 and 24 weeks, respectively(12 and 24 weeks)
研究者
Qianjin Lu, MD, PhD
Professor and Director, Institute of Dermatology, The Second Xiangya Hospital of Central South University
Second Xiangya Hospital of Central South University