Botulinum Toxin-A for Hidradenitis Suppurativa
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Number of lesions
研究概览
简要总结
The purpose of this research study is to determine if the medication Botulinum Toxin-A (BTX-A) is effective in treating hidradenitis suppurativa (HS)
详细描述
Hidradenitis suppurativa (HS) is an auto-inflammatory disorder of apocrine sweat glands which results in painful, draining nodules within hair-bearing skin of the axillae, groin, and perineum. There is no consensus for treatment of HS and neither a medical nor surgical cure exists. Several case reports show potential efficacy of Botulinum Toxin-A (BTX-A) in inducing remission of HS however, these studies are underpowered. The objective of this study is to determine if Botulinum Toxin- A induces regression, remission, or relapse of hidradenitis suppurativa lesions.
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
- Double (Participant, 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
- •Subjects with active axillary hidradenitis suppurativa of the same severity bilaterally. regimen
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
- •Agreement to forego other treatments for hidradenitis for the duration of the study
排除标准
- •Current use of antibiotics, hormonal therapies, steroids, and/or biologics
- •Presence of cardiac pacemaker
- •Pregnancy or lactation
- •Known neuromuscular disorder
- •Known hyperhidrosis
- •Febrile illness within one month
- •Treatment with another investigational drug or other intervention within three months
- •Patients without active axillary hidradenitis suppurativa
研究组 & 干预措施
Experimental
During their treatment visit, subjects will receive Botulinum Toxin-A in one axillae and normal saline in the other, in a double-blinded fashion.
干预措施: Botulinum toxin type A (Drug)
Placebo Comparator
At three months, Group 1 subjects will receive 50-units BTX-A and NS in the same axillae as before while Group 2 will receive NS in both axillae.
干预措施: Normal saline (Drug)
结局指标
主要结局
Change in Number of lesions
时间窗: baseline and 3 months
Change in number of lesions (nodules, abscesses, and fistulous tracts). Any changes in lesion count or size will be documented and subjective symptoms such as pain will be noted.
次要结局
- Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score(baseline, 3 months and 6 months)
- Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa(3 months, 6 months, 12 months)