A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Clinical change of alopecia from baseline to 150 days.
研究概览
简要总结
This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. Follow-up is at 150 days.
This study was a pilot study designed to determine feasibility of this procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ≥ 18 years old
- •Subjects are in good health as judged by the investigator.
- •Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
- •Subject is seeking treatment for alopecia.
- •Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
- •Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
排除标准
- •Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
- •Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
- •Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
- •History of recurrent facial or labial herpes simplex infection
- •History of hypertrophic scars or keloids
- •Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
- •Pregnant or breast feeding
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Subjects who are unable to understand the protocol or give informed consent.
结局指标
主要结局
Clinical change of alopecia from baseline to 150 days.
时间窗: Baseline and 150 Days
Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University