Comparative Efficacy of Nd:YAG and Alexandrite Laser Treatments in Hidradenitis Suppurativa: A Split-Person, Non-Inferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 21
- 主要终点
- HiSCR50
研究概览
简要总结
The purpose of this study is to evaluate whether Alexandrite laser treatment is non-inferior to Nd:YAG (neodymium-doped yttrium aluminum garnet) laser treatment of hidradenitis suppurativa (HS).
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 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Geisinger male or female patients with a diagnosis of hidradenitis suppurativa (all stages of disease)
- •12-75 years of age
- •Not on concurrent systemic therapy (e.g., antibiotics, biologic therapies)
- •Must have not used systemic therapies within 2 weeks of enrollment in study
- •Able and willing to provide consent
排除标准
- •Patients who cannot tolerate laser therapy
- •Patients who cannot wear protective eyewear
- •Patients who are pregnant
研究组 & 干预措施
Receiving treatment with both laser types
Participants will receive split-body treatment, receiving Nd:YAG laser treatment to an affected anatomical site (axilla, inframammary region, or groin) and Alexandrite laser to the contralateral side. The treatment side will be randomized and maintained through the study.
干预措施: Nd:YAG Laser (Device)
Receiving treatment with both laser types
Participants will receive split-body treatment, receiving Nd:YAG laser treatment to an affected anatomical site (axilla, inframammary region, or groin) and Alexandrite laser to the contralateral side. The treatment side will be randomized and maintained through the study.
干预措施: Alexandrite Laser (Device)
结局指标
主要结局
HiSCR50
时间窗: 6 months
Percentage of patients achieving a 50% reduction in their hidradenitis suppurativa clinical response (HiSCR) score.
HiSQOL
时间窗: 6 months
The Hidradenitis Suppurativa Quality Of Life (HiSQOL) scale, a validated HS quality of life index and is comprised of a 17-item HS-specific HRQOL instrument with a 7-day recall period. Score ranges from 0 to 68, with higher scores indicating more severe impact
次要结局
- Pain VAS score(6 months)
- Pruritus numeric rating scale(6 months)
- Days free of disease in last 30 days(6 months)
- AN Count(6 months)
研究者
Mickey Horissian
Assistant Professor of Dermatology
Geisinger Clinic