The Reflection of Skin Color on the Efficacy of Narrow Band UVB in Stabilization of Active Cases of Vitiligo
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Detecting number of participants with clinical activity of vitiligo
研究概览
简要总结
Vitiligo is a disease in which autoimmunity plays a major role. Multiple treatment options are available, of which narrow-band UVB is a cornerstone, acting through immunosuppression and repigmentation by stimulating reservoir melanocytes.
It's expected that this immunsupression is lower in darker skin types, where increased basal melanin might act as a barrier.
详细描述
Vitiligo is acquired depigmentation disorder. Several theories were hypothesized for causing vitiligo, of which the autoimmune theory is the most accepted.
The main targets of therapy are stabilization of the disease activity through immunosuppression, and repigmentation through stimulation of reservoir melanocytes proliferation and migration.
Narrow band ultraviolet phototherapy (NB-UVB) remains the cornerstone treatment of vitiligo. NB-UVB can induce both immunosuppression and repigmentation. Several factors can modulate the efficacy of NB-UVB therapy in treatment of vitiligo cases, including patient's age, lesion site, duration of the disease, and duration of the therapy.
The immunosuppressive function of NB-UVB was first detected in 1963 by Hanisko and Suskind, who observed that the contact hypersensitivity response in skin sensitized to dinitrochlorobenzene (DNCB) was reduced if skin was previously exposed to suberythemal doses of UVB.
Present evidence suggests that UVB suppress immune system through generation of T-suppressor cells, which inhibit the effector cells of Th1 type. It appears that UV-induced immunosuppression depresses the function of Th1 cells and enhances the activity of Th2 cells via cytokines such as Interleukin 10.
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 (Care Provider)
盲法说明
Masking involves only oral therapy; 100 patients will be randomized into 2 groups; 50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week while the other 50 patients will receive placebo having the same color, form and packaging for 6 months.
The investigators are blinded.
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active cases of non-segmental vitiligo, VIDA +2 or more.
- •All skin types
- •Age above 6 years, both sexes.
排除标准
- •Contraindications to NB-UVB ( photosensitive skin disorders, skin malignancy, patients on photosensitizing medications)
- •Contraindications to mini-pulse steroid therapy (uncontrolled diabetes or hypertension, peptic ulcer)
- •Stable disease (VIDA 0 & -1) and activity more than 6 months ago (VIDA +1).
- •The use of other treatment for vitiligo during the 3 months previous to enrollment.
研究组 & 干预措施
Active
50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.
干预措施: Oral dexamethasone minipulse (Drug)
Placebo
50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Detecting number of participants with clinical activity of vitiligo
时间窗: At 6 months after treatment.
Appearance of new lesions or expansion of pre-existing lesions by clinical examination.
Photography to detect activity of vitiligo
时间窗: Change from baseline (first visit) at 6 months after treatment.
New lesions in each area will be counted.
Elevation of serum Vitiligo activity markers.
时间窗: Change from baseline at 6 months after treatment.
A 5 cc blood sample will be withdrawn from each patient for: ELISA assessment of CXCL-10 (Pg/ml)
Elevation of PCR levels of serum Vitiligo activity markers
时间窗: Change from baseline at 6 months after treatment.
A 5 cc blood sample will be withdrawn from each patient for: PCR assessment of m-RNA of CXCL-10 as markers of disease activity.
次要结局
未报告次要终点
研究者
Mahy El-Bassiouny
Assistant Lecturer
Ain Shams University