Latanoprost Plus NB-UVB Versus Each Alone in Non-segmental Vitiligo: Clinical and Laboratory Evaluation
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- serum TWEAK in vitiligo
研究概览
简要总结
The aim of the study is to evaluate the efficacy of different lines of therapies on the TWEAK serum level in patients with non-segmental vitiligo.
详细描述
the study is to evaluate the efficacy of NB-UVB, latanoprost, and combination of them on the TWEAK serum level in patients with non-segmental vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with non-segmental vitiligo of any age and gender.
排除标准
- •History of vitiligo treatment with topical, systemic or biological agents prior to the study for at least 3 weeks.
- •Pregnancy and lactation.
- •Infections
- •Patients with other autoimmune diseases.
- •Patients with chronic diseases: cardiac diseases, hepatic disorders, hematologic disease, chronic renal failure or malignancies.
研究组 & 干预措施
NB-UVB radiation
will expose to 2 sessions/week of NB-UVB radiation, for 3 months.
干预措施: NB-UVB (Radiation)
Latanoprost
latanoprost 0.005%, will be applied after microneedling, by using 1.5-2 mm needle length dermapen, of vitiligenous patches. The procedure will be repeated once weekly for 3 months (12 sessions).
干预措施: Latanoprost (Drug)
latanoprost + NB-UVB
(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.
干预措施: NB-UVB (Radiation)
latanoprost + NB-UVB
(latanoprost + NB-UVB group): latanoprost 0.005%, will be applied after microneedling of vitiligenous patches in the same day of NB-UVB sessions in the same manner of group 2.
干预措施: Latanoprost (Drug)
结局指标
主要结局
serum TWEAK in vitiligo
时间窗: 3months
measurement of serum Tumor necrosis factor weak inducer of apoptosis (TWEAK)"pg/ml"; in vitiligo patients before and after treatment with NB-UVB, Latanoprost and their combination, all in comparison with healthy individuals, using ELISA (enzyme-linked immunosorbent assay)
次要结局
- treatment of vitiligo(3 months)
研究者
Shaimaa Fawzy Abdel-rady Abdel-latif
investigator
Aswan University Hospital