Maintenance Therapy of Narrow-band UV-B Therapy in Patients With Vitiligo
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrence of vitiligo
研究概览
简要总结
Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy.
The aim of this study was to evaluate the efficacy of Narrow-band UV-B therapy for the prevention of relapse in vitiligo.
详细描述
For a total period of 12 months, perform Narrow-band UV-B treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.
An independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.
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
- None
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
- •Patients with age of 19 years or older
- •Patients of generalized vitiligo with lesions on the trunk
- •Patients who had treated with Narrow-band UV-B therapy previously and achieved more than 75% lesion improvement
- •Patients who voluntarily agreed to participate in the study
排除标准
- •Patients under the age of 19
- •Patients with localized vitiligo and segmental vitiligo
- •Patients who are in a state of physical or mental impairment to perform treatment or pregnant
- •Patients with spreading of vitiligo lesions
- •Patients who do not want to do thie study or who refuse to write a consent form
- •Any other person deemed unsuitable for the examination at the discretion of the examiner
研究组 & 干预措施
Experimental group
- For a total period of 12 months, perform Narrow-band UV-B therapy treatment once a month.
- At this time, the dose of Narrow-band UV-B therapy therapy is based on the 50% of the maximum dose that the patient received for the treatment.
干预措施: Narrow-band UV-B therapy (Device)
Control group
- Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.
- If recurrence of vitiligo is observed during the follow-up period, visit the clinic and check for recurrence.
结局指标
主要结局
Recurrence of vitiligo
时间窗: change from baseline area score at 12 months
Clinical photographs taken before and 12 months after the completion of the study. The photographs will be used to measure the area of vitiligo lesion, and the investigators will compare the area score and judge whether or not there is a recurrence.
次要结局
- The assessment of patient satisfaction(at baseline and at 12 months)
研究者
Jung Min Bae
Assistant Professor
The Catholic University of Korea