Adipose-derived Stem Cells Combined With Excimer Light in the Treatment of Stable Vitiligo
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Vitiligo Disease Activity (VIDA) Score
研究概览
简要总结
This study aimed to assess the efficacy and safety of intradermal injection of adipose-derived stem cells, alone and combined with excimer light in treatment of stable vitiligo.
详细描述
Vitiligo is a common disfiguring autoimmune disease that negatively affects patients' self-esteem and quality of life. Vitiligo is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin.
Adipose tissue-derived stem cells have the capacity to secrete a variable cytokines and growth factors, including hepatocyte growth factor (HGF), interleukin-6 (IL-6), macrophage colony-stimulating factor (M-CSF), transforming growth factor-β1 (TGF-β1), tumour necrosis factor (TNF), vascular endothelial growth factor (VEGF), that stimulate angiogenesis, tissue remodeling, and anti-apoptotic processes. Phototherapy has an eminent effect on stoppage of progression and repigmentaion of vitiligo patches. Narrowband ultraviolet B (NB-UVB) and ultraviolet A (UVA), and monochromatic excimer light (MEL) can be used in treatment of vitiligo. The specific 308-nm radiation wavelength is delivered in a targeted form by the xenon-chloride excimer laser and is also available in an incoherent form that is commonly referred to as the excimer lamp.
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
- 15 Years 至 52 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with two or more similar patches of stable vitiligo "absence of new patches of depigmentation or enlargement of the pre-existing patches" for 6 months at least.
- •Patients who will accept to be enrolled in the study and will sign an informed consent.
排除标准
- •Unstable vitiligo for more than 6 months.
- •Current bacterial or viral infection in the treatment area.
- •Patients with unrealistic expectation.
- •Very thin patients "poor donor areas".
- •Patients with uncontrolled systemic disease such as diabetes or hypertension.
- •Patients with hepatitis B or C virus infection.
- •Patients with any other skin disease.
- •Patients with bleeding or coagulopathy disorders.
- •Pregnancy and lactation.
- •Patients who received topical treatment for vitiligo during the last month, or systemic treatment during the past three months before the study.
结局指标
主要结局
Vitiligo Disease Activity (VIDA) Score
时间窗: 6 months post-procedure
The Vitiligo Disease Activity (VIDA) Score is a 6-point clinical scale used to measure the progression or stability of vitiligo. The scale ranges from -1 to +4, where higher numbers indicate more recent and rapid disease activity: * 4: Active disease (new lesions or expansion) within the last 6 weeks. * 3: Active disease between 6 weeks and 3 months. * 2: Active disease between 3 and 6 months. * 1: Active disease between 6 and 12 months. 0: Stable disease with no changes for 1 year or longer. * 1: Stable for 1 year or longer, showing signs of spontaneous repigmentation
次要结局
未报告次要终点
研究者
Samar El-Sayed Abdel Hamid Gad
Assistant Lecturer of Dermatology and Venereology, Faculty of Medicine, Tanta University, Egypt
Tanta University