Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
The study will compare the effectiveness of combined treatment with NB-UVB and tacrolimus versus NB-UVB alone . Patients will be treated for 6 months and followed up after 3 months .All types of vitiligo will be included except universal vitiligo.
详细描述
Study approval:
The study will be submitted for approval by the Scientific and Ethical Committees at Faculty of Medicine, South Valley University, Qena. An informed written consent will be obtained from all participants.
Study design:
A randomized controlled trial.
Study population:
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
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with clinical diagnosis of vitiligo.
排除标准
- •Patients with universal vitiligo, women who are pregnant or lactating at the time of recruitment, children ≤ 2 years old, patients with acute or chronic disease that might affect skin barrier function or patients with history of photosensitivity.
结局指标
主要结局
Vitiligo Area Scoring Index (VASI)
时间窗: baseline to 9 months
The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites \[Hand Units\] ´ \[Residual depigmentation\].
次要结局
- Vitiligo Disease Activity (VIDA) score(baseline to 9 months)
研究者
Noha Samir
Dermatology resident at South Valley University Students' Hospital
South Valley University