Efficacy of 311-nm Ti:Sapphire Laser Versus 308-nm Excimer Laser Treatment in Vitiligo
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- The repigmentation rate (change from baseline) of the vitiliginous patch
研究概览
简要总结
A randomized controlled non-inferiority trial based on split-body was planned to compare the efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.
详细描述
The 308-nm excimer laser (EL) has been widely used for localized vitiligo. Recently, the 311-nm Ti:Sapphire laser (TSL) was developed to treat patients with vitiligo. To compare the efficacy of TSL vs. EL in the treatment of vitiligo.
A randomized controlled non-inferiority trial based on split-body was planned. The paired symmetric vitiliginous lesions will be randomized to either TSL or EL treatment groups. All lesions will be treated twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks, and the non-inferiority margin was set at 10%. Overall 16 patients will be enrolled.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: older than 19
- •A patient with stable non-segmental vitiligo
- •A patient with symmetrical vitiligo lesions
- •A patient with the willingness to comply with the study protocol during the study period and capable of complying with it
- •A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
排除标准
- •Age: lower than 20
- •A pregnant or lactating patient
- •A patient with active or spreading vitiligo
- •A patient who cannot understand the study or who does not sign the informed consent
研究组 & 干预措施
The 311-nm Ti:Sapphire laser treatment group
All lesions were treated twice weekly for a total of 12-week period.
干预措施: 311-nm Ti:Sapphire laser (Device)
The 308-nm excimer laser treatment group
All lesions were treated twice weekly for a total of 12-week period.
干预措施: 308-nm excimer laser (Device)
结局指标
主要结局
The repigmentation rate (change from baseline) of the vitiliginous patch
时间窗: Baseline and 12 weeks
The degree of repigmentation will be assessed as % from baseline by using a computer program.
次要结局
- The adverse effects of both two laser treatments(At 4 weeks, 8 weeks, and 12 weeks)
研究者
Jung Min Bae
Clinical Assistant Professor
The Catholic University of Korea