The Efficacy of Hand-Foot Narrow-Band Ultraviolet B (UVB) Versus Focal 308-nm Treatment in Inducing Repigmentation of Vitiligo After Minigrafting on the Dorsal Hands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Percent Repigmentation of Target Lesion
研究概览
简要总结
To assess over a 25-week period the efficacy of hand-foot narrow-band ultraviolet B light versus focal 308-nm light treatment in inducing the return of pigment in vitiligo after skin minigraft transplants to the backs of the hands in patients with light brown to black skin. Subject will undergo treatment for 13 weeks.
详细描述
Prospective investigator-blinded study involving 13 adult male and female subjects with vitiligo on the backs of both hands. Punch minigrafting will be performed on both hands taking skin from the thighs and/or buttocks. Light treatments will be administered starting at week one after grafting. One hand will receive narrow-band ultraviolet B light and the other will receive focal 308-nm light treatments. Light treatments will be administered 3 times per week for 12 weeks. A long term follow-up visit will be completed at week 25. The investigator will evaluate the subjects at week 4, 7, 13 and 25 in addition to screening and baseline evaluations/procedures.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects 18 years of age or older
- •skin type III-VI
- •vitiligo on both dorsal hands
- •history of stable vitiligo ( no new lesions and no more than 10% enlargement of existing lesions) for six months with an absence of Kebner phenomenon (new lesions appearing after trauma to the skin)
- •refractory to topical steroids and immunomodulators
排除标准
- •pregnant and/or breast-feeding females
- •history of skin cancer
- •history of taking photosensitizing medications
- •history of recent phototherapy (light therapy) or topical medications within one month prior to enrollment
- •history of organ transplantation
- •history of failed vitiligo skin transplantation
- •history of segmental vitiligo
- •history of 12 or more continuous light treatments
研究组 & 干预措施
Daavlin Right vs. Excilite Left
Right hand treated with narrow-band UVB light and left hand treated with focal 308nm light.
干预措施: NBUVB (Device)
Excilite Right vs. Daavlin Left
Right hand treated with focal 308-nm light and left hand treated with narrow-band UVB light
干预措施: Monochromacitc Excimer light (Device)
结局指标
主要结局
Percent Repigmentation of Target Lesion
时间窗: 25 weeks
This is measured using photography and Scion software calculations.
次要结局
未报告次要终点