Efficacy and Safety of UVB Excimer Light in Alopecia Areata: A Prospective, Single-Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in the percentage of hair regrowth for each half. We will consider the treamtment successful if there was ≥50% hair regrowth from baseline.
研究概览
简要总结
Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.
详细描述
Alopecia Areata (AA) is a chronic autoimmune inflammatory disease causing nonscarring hair loss. Many treatment modalities have been found to be helpful in AA, however, none on them cure the disease.
Excimer laser has been shown to be effective in the treatment of AA in controlled studies. The main disadvantage of the previous studies evaluating excimer laser is choosing separate patches as a control which does not account for interlesional treatment response variability. UVB excimer light has recently emerged as a new therapeutic modality in many dermatologic diseases. However, there are only a few studies that evaluated the efficacy and safety of UVB excimer light in AA. Those studies have shown that UVB excimer light is effective in the treatment of AA but none of them was conducted in a controlled fashion.
There are no prospective randomized controlled trials evaluating the efficacy and safety of UVB excimer light in AA. We plan on conducting a prospective split lesion single-blinded randomized clinical trial to assess efficacy and safety of UVB excimer light in the treatment of AA.
Study Objectives
- To evaluate the potential for UVB excimer light to induce hair regrowth within AA patches.
- To assess the side effect profile of UVB excimer light when used in the treatment of AA.
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.
- •Subject has a patch of at least 12 cm2 on the scalp with no evidence of hair regrowth.
- •Subject is willing and capable of cooperating to the extent and degree required by the protocol.
排除标准
- •Patients who received treatment for alopecia areata within the past 4 weeks.
- •Patients with alopecia totalis or alopecia universalis.
- •Patients with known photosensitivity like having polymorphous light eruption, connective tissue diseases, porphyria or Xeroderma pigmentosum.
- •Pregnancy or breast-feeding.
- •History of previous skin cancer.
- •Patients that have participated in another investigational drug or device study within 30 days of enrollment.
结局指标
主要结局
Change in the percentage of hair regrowth for each half. We will consider the treamtment successful if there was ≥50% hair regrowth from baseline.
时间窗: at 6, 12, and 16 weeks from baseline
次要结局
- Change in hair count and caliber in each half(at 6, 12, and 16 weeks from baseline)
- Assessment of side effects in each half(at 6, 12, and 16 weeks from baseline)