Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment.
研究概览
简要总结
OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the conventional continuous excimer laser treatment.
DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was performed in two tertiary health care centers in Korea.
PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than 5 years' disease duration were enrolled.
INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic on-off treatment. All lesions were treated twice weekly for 9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total 3 cycles). Topical tacrolimus was applied throughout the trial.
OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with clinical photographs. The primary outcome was mean difference of repigmentation rates and the non-inferiority margin was set at 10%. During intermission period, the clinical changes such as loss of repigmentation or worsening of the vitiligo lesions were assessed.
详细描述
[Study design and population] A randomized, controlled, split-body, non-inferiority trial was designed.
After obtaining informed consent, 12 patients with stable symmetric vitiligo less than 5 years' disease duration were enrolled.
The patients taking systemic steroids or having enlarging lesions were excluded. The paired symmetric vitiliginous lesions were randomized to either the continuous or the cyclic excimer laser treatment.
Total duration of study was 9 months.
In cyclic excimer laser treatment, the cycle was arbitrarily determined that one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off) (total 3 cycles during the trial).
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with symmetric vitiligo
- •Patients with less than 5 years' disease duration
排除标准
- •The patients taking systemic steroids
- •The patients with currently enlarging lesions
- •The patients who cannot follow the treatment schedule
研究组 & 干预措施
continuously excimer laser treatment
In this group, lesions treated twice weekly through out the whole trial length (9 months).
Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).
干预措施: Topical tacrolimus 0.1% ointment (Drug)
cyclic excimer laser treatment
In this group, one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off).
Total 3 cycles of cyclic treatment through out the whole trial length (9 months). During the treatment period, lesions treated twice weekly.
Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).
干预措施: Topical tacrolimus 0.1% ointment (Drug)
cyclic excimer laser treatment
In this group, one cycle consists of a 2-month treatment period (on) and a consecutive 1-month intermission period (off).
Total 3 cycles of cyclic treatment through out the whole trial length (9 months). During the treatment period, lesions treated twice weekly.
Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).
干预措施: The XTRAC Excimer Laser System (Device)
continuously excimer laser treatment
In this group, lesions treated twice weekly through out the whole trial length (9 months).
Application of topical tacrolimus 0.1% ointment through out the whole trial length (9 months).
干预措施: The XTRAC Excimer Laser System (Device)
结局指标
主要结局
Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment.
时间窗: Through study completion, an average of 9 months
The degree of repigmentation was assessed with a repigmentation rate (%) with clinical photographs by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea).
次要结局
未报告次要终点
研究者
Jae Min Sung
Resident of the department of dermatology
Ajou University School of Medicine