UVA 1 Phototherapy for Vitiligo
试验速览
- 阶段
- 2 期
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change in the modified VASI score compared to baseline.
研究概览
简要总结
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin. There are many treatment modalities available for vitiligo, however, none of them cure the disease. Ultraviolet A1 (UVA1) phototherapy has been shown to be useful for a variety of skin diseases. However, there are only a few studies published on the efficacy of UVA1 in vitiligo. This is a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.
详细描述
Vitiligo is a chronic acquired disease characterized by well defined white macules and patches affecting the skin and mucous membranes. Mucocutaneous lesions develop secondary to selective destruction of melanocytes. The etiology of vitiligo is largely unknown but more likely to be multifactorial. There are several theories on the pathogenesis of vitiligo including mainly the autoimmune, neurohormonal, and autocytotoxic theories. The autoimmune hypothesis has the strongest evidence with alteration mainly in the cellular immune response.
There are many treatment modalities available for vitiligo, however, none of them cure the disease. These include different topical treatments, phototherapy, surgical therapy, and depigmentation therapy. Narrow-band UVB (NB-UVB) is currently the preferred treatment over topical psoralen and ultraviolet A radiation (PUVA), for patients with vitiligo. However, overall response of vitiligo to NB-UVB has been variable. Ultraviolet A1(UVA1) phototherapy is now useful for a variety of skin diseases, specifically scleroderma. There are only a few studies published on the efficacy of UVA1 in vitiligo.
One of the main side effects of UVA1 is prominent tanning which might be due to melanocyte stimulation. Therefore, the investigators hypothesis is that UVA1 will induce significant skin pigmentation to improve vitiligo. The investigators plan on conducting a prospective single-blind randomized clinical trial to assess efficacy and safety of UVA1 in the treatment of vitiligo.
Study Objectives
- To evaluate the potential for UVA1 to induce repigmentation within vitiligo patches.
- To assess the side effect profile of UVA1 when used in the treatment of vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Localized or generalized vitiligo that involves a non mucosal or acral site.
- •Patients should have a patch of at least 25 cm2 that shows no more than 10% repigmentation as assessed visually
排除标准
- •Patients who received treatment for vitiligo within the past 3 weeks.
- •Patients known to have a photosensitivity disorder
- •History of previous skin cancer.
- •History of severe medical illness or immunosuppression.
- •Pregnancy or breast-feeding.
结局指标
主要结局
Change in the modified VASI score compared to baseline.
时间窗: assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment
次要结局
- Assessment of side effects in each half including erythema, pruritus, and polymorphous light eruption(assessments at 2, 4, 6, and 8 weeks during treatment then at 4, 8, and 12 weeks post treatment)