Assessment of the Combined Effect of Acitretin and Narrow Band Ultraviolet B (Nb-UVB) on the Clinical Repigmentation and on the Expression of E-cadherins in Vitiligo Lesions in Comparison to Narrow Band UVB Alone. A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
研究概览
简要总结
Since abnormal keratinocyte (KC) proliferation and differentiation as well as defective E cadherin expression were reported in vitiligo lesions, the investigators set to study the potential efficacy of combining Retinoids, which are known to improve KC proliferation and differentiation and increase the expression of adhesion molecules, with narrowband UVB in the treatment of vitiligo.
详细描述
• Twenty patients with generalized vitiligo will be included in this study.
All patients will be subjected to:
- Clinical evaluation:
- An informed written consent.
- History taking include age, previous treatment, disease activity
- Clinical examination including Vitiligo Area Scoring Index (VASI) and Vitiligo Disease Activity Score (VIDA)
- Photography (before starting the treatment and every 2 weeks till the end of the study)
Laboratory evaluation:
- 2 mm punch skin biopsies will be taken from vitiligo patients, 1 from lesional and the other from perilesional skin before treatment.
- The patients will be randomly assigned to two groups:
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with generalized non-segmental vitiligo (25%-75%)
- •Males, postmenopausal females and premenopausal females not planning to get pregnant during the period of treatment and after 2 years from the end of treatment.
- •Age more than 18 years.
排除标准
- •Children ˂ 18 years old
- •Pregnant females
- •Premenopausal females planning to get pregnant within the period of treatment or within 2 years after.
- •Patients receiving treatment for vitiligo within the past 2 months.
- •Patients with abnormal liver profile
- •Patients with abnormal lipid profile
- •Patients with associated photosensitive disorders
- •Patients having associated skin diseases other than vitiligo
- •Cataract and aphakia
- •High cumulative dose from previous sessions of narrowband ˃ 200-300 session
研究组 & 干预措施
NbUVB
Group A: patients will receive three NB-UVB sessions per week for 48 sessions.
干预措施: Narrow band ultraviolet B (Other)
Combined nbUVB and Acitretin
Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
干预措施: Acitretin (Drug)
Combined nbUVB and Acitretin
Group B: patients will receive three NB-UVB sessions per week for 48 sessions combined with acitretin in a dose of 0.3mg/kg/day daily.
干预措施: Narrow band ultraviolet B (Other)
结局指标
主要结局
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Area Scoring Index
时间窗: 4-5 months
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Area Scoring Index (VASI)
Determining whether addition of acitretin is beneficial for vitiligo patients or not using Vitiligo Disease Activity Score.
时间窗: 4-5 months
The number of patients who will achieve 100%, 75% and 50% repigmentation of vitiligo lesions will be compared between group A (nbUVB) and group B (nbUVB+ acitretin) after 48 nbUVB sessions. The comparison of the 2 groups will be assessed using Vitiligo Disease Activity Score (VIDA).
次要结局
未报告次要终点