Pilonidal Disease Laser Depilation Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Tolerability of Laser Treatment
研究概览
简要总结
Pilot study to assess tolerability and safety of laser hair depilation in adolescents and young adults with pilonidal disease.
详细描述
This is a pilot study to measure safety and tolerance of laser hair depilation in adolescents and young adults with pilonidal disease as a potential treatment to intervene on future recurrence.
Up to a total of 10 patients will be enrolled.
Each patient will be involved in the study for one year. Patients will be brought into Surgery clinic for 1 laser treatment every 4-6 weeks to obtain a total of 5 treatments. Follow up will occur monthly from the time of initial treatment through 1 year after the last treatment as we evaluate for tolerance and efficacy.
Inclusion Criteria
- English and non-English speaking patients
- All Fitzpatrick skin types
- Age : 12-20 years
- Diagnosis of pilonidal disease
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
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English and non-English speaking patients
- •All Fitzpatrick skin types
- •Age : 12-20 years
- •Diagnosis of pilonidal disease
排除标准
- •History of photosensitivity
- •Actively inflamed pilonidal sinus
研究组 & 干预措施
Laser depilation
Laser depilation to the natal cleft (pilonidal region) monthly for 5 treatments with either an 810nm of Nd:YAG laser dependent on Fitzpatrick skin type and tolerability.
干预措施: Laser depilation (Device)
结局指标
主要结局
Tolerability of Laser Treatment
时间窗: five months
Median of pain scores immediately post-laser treatment after each of the 5 treatments. Pain was assessed on a scale of 1 to 10, 10 being the greatest amount of pain.
次要结局
- Number of Participants Experiencing Second Degree Burns Post-Treatment(five months)
研究者
Peter Minneci
Principal Investigator
Nationwide Children's Hospital