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Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa (Botox in HS)

2026年9月8日 更新者：Sarah Whitley、University of Massachusetts, Worcester
This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease hidradenitis suppurativa (HS). In this study, the investigators will extend data from a 12-week pilot study to rigorously test the hypothesis that botulinum toxin (BoNT) therapy reduces disease severity and relieves HS pain symptoms..

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study will recruit 40 HS patients with an abscess and inflammatory nodule (AN) count ≥5 at a single body site (ex. bilateral axillae, medial thighs). Participants will be randomized 1:1 to receive placebo or 50U of BoNT per 100cm2 of skin (100U total) administered twice over a 6-month study period. Randomization will be stratified by disease stage (Hurley stage <III, III). At baseline and weeks 4, 12, and 24 disease activity and pain symptom burden will be measured using percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count as primary outcomes and achievement of ≥ 30% reduction from baseline in the Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS)-30 as a secondary outcome. The investigators will conduct high-frequency ultrasound measurement of HS tunnel area at baseline and weeks 4,12, and 24 to determine if BoNT therapy can reduce tunnel size. The study team will also collect punch biopsies of lesional skin from HS patients before, and 4 weeks after BoNT treatment then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if and how nonselective inhibition of neuropeptide release diminishes HS inflammation.

研究类型

介入性

注册 (估计的)

40

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Massachusetts
      • Worcester、Massachusetts、美国、01605
        • UMass Chan Medical School
        • 接触：
        • 接触：
        • 首席研究员：
          • Sarah K Whitley, MD, PhD
        • 副研究员：
          • Jessica St. John, MD, MPH
        • 副研究员：
          • Sidney Leno, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age >13 and <75
  • established diagnosis of HS
  • HS skin lesions of duration at least 1 year
  • HS lesions in at least two distinct body areas
  • inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics
  • abscess and nodule (AN) count ≥ 5 at baseline
  • draining tunnel count of <20 at baseline
  • ability to provide written informed consent and/or assent

Exclusion Criteria:

  • pregnant or breastfeeding
  • history of neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy
  • medical co-morbidity ex. end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure
  • received systemic steroids or started a new systemic (biologic or non-biologic immunomodulator, oral retinoid) therapy with potential therapeutic impact for HS <12 weeks prior to baseline visit
  • use of opioid or non-opioid oral analgesics within 14 days of baseline visit (exception: at a stable dose for at least 14 days prior to baseline)
  • receiving anti-IL-17A/F, anti-IL-23, or anti-IL-1 biologic therapy or oral JAK inhibitor, TYK inhibitor
  • active COVID-19 infection or history of COVID-19 infection within 4 weeks prior to baseline
  • oral or IV antibiotic use during the treatment period (exception: stable dose of doxycycline or minocycline upto 100mg PO BID for 28 days prior to baseline and throughout the 6 month treatment and observation period
  • initiation of topical therapies for HS within 14 days or baseline visit (may continue stable use of topical therapies started > 14 days prior to baseline visit), -laser surgery, laser hair removal, or elective surgery to treatment areas within 4 weeks prior to baseline visit
  • current participation in another clinical study involving the administration of an investigative drug for the treatment of HS, or prior participation in such a study within 60 days prior to baseline visit,
  • active bacterial, fungal, or viral infection in the treatment area at baseline visit, -immunocompromised state
  • known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：placebo
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
药品：Placebo
10 injections of 0.1mL of normal saline vehicle per laterality
其他名称：
  • 盐水
有源比较器：botulinum toxin
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
药品：Botulinum Toxin A (Allergan, Inc, Irvine CA)
50U per axilla in 10 injections of 0.1mL

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
大体时间：baseline and weeks 4, 12, and 24
All subjects will receive 2 treatments with onabotulinum toxin A OR placebo (saline) 3 months apart, over a 6-month study period. At baseline and at week 12 each patient will receive 50 units of Botox per 100cm2 of skin, injected intradermally in 10 injections of 0.1mL spaced 1 cm apart to one HS-affected body site (ex. bilateral axillae, inguinal, medial thighs, inframammary chest) for a total of 100U per treatment.
baseline and weeks 4, 12, and 24
Microscopy Analyses of Skin Lesions
大体时间：baseline and day 7
The study team will perform punch biopsies of lesions and non-lesional skin and perform direct immunohistochemistry and immunofluoresce microscopy analysis
baseline and day 7
Ultrasound monitoring of skin lesions
大体时间：baseline and weeks 1, 12, 24
Ultra-high frequency ultrasound (UHFU): This non- invasive imaging technique will be used to quantify HS tunnel area and cutaneous blood flow rate in treatment areas using an established protocol as detailed in Oranges T Skin Res Technology 2020).
baseline and weeks 1, 12, 24

次要结果测量

结果测量
措施说明
大体时间
Dermatology Quality of Life Index
大体时间：baseline and weeks 1, 12, 24
Assesses the degree of pain, the number of flares, and the impact on daily life . Dermatology disease agnostic, not specific for HS
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)
大体时间：baseline and weeks 1, 12 ,24
Response is defined as at least a 2-point reduction in HS-IGA score relative to baseline.
baseline and weeks 1, 12 ,24
Central sensitization Index (CSI)
大体时间：baseline and weeks 1, 12, 24
measures centrally processed pain signals. The participant scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitization.
baseline and weeks 1, 12, 24
Numeric Rating Scale -30
大体时间：baseline and weeks 1, 12, 24
The numeric rating scale (NRS) is a pain scale that asks a patient to rate their pain on a scale of 0 to 10 where a higher score indicates a higher pain level. It's a common tool used in healthcare to assess pain severity.
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Clinical Response (HiSCR)-50
大体时间：baseline and weeks 1, 12, 24
defined as a 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules) with no increase in abscesses or draining fistulas when compared with baseline.
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
大体时间：baseline and weeks 1, 12, 24
The six-point Hidradenitis Suppurativa Physician Global Assessment (PGA) ranges from clear to very severe where a higher score indicates more severe disease. It is used in clinical trials to measure clinical improvement in inflammatory nodules,abscesses and draining fistulae
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Quality of Life (HiSQOL)
大体时间：baseline and weeks 1, 12, 24
A 17-item questionnaire designed to measure quality of life for people with HS. Scores range from 0-68 where higher scores indicate a worse impact on quality of life.
baseline and weeks 1, 12, 24
International Hidradenitis Suppurativa Severity Score (IHS-4)
大体时间：baseline and weeks 1, 12, 24
The International Hidradenitis Suppurativa Severity Score (IHS4) is a validated tool that measures the severity of hidradenitis suppurativa (HS). The IHS4 score is calculated by adding the number of nodules, abscesses, and draining tunnels, each multiplied by a weight A score of 3 or less indicates mild HS, 4-10 indicates moderate HS, and 11 or higher indicates severe HS. The IHS4 is used to assess the severity of HS and to measure inflammatory lesions, such as draining tunnels.
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Area and Severity Index Revised
大体时间：baseline and weeks 1, 12, 24
The HASI-R method assesses HS severity in a manner that incorporates signs of inflammation and body surface area involved. Scores range from 0-720 where a higher score indicates worse disease.
baseline and weeks 1, 12, 24
Numeric Rating Scale - Itch
大体时间：baseline and weeks 1, 12, 24
rates itch score as 1-10, 10 indicating most severe itch. similar to NRS pain instrument
baseline and weeks 1, 12, 24
PainDETECT
大体时间：baseline and weeks 1, 12, 24
an assessment tool for neuropathic pain. Scores range from -1 to 38. A score of 19 or higher indicates neuropathic pain is likely.
baseline and weeks 1, 12, 24
Generalized Anxiety Disorder-7 (GAD-7)
大体时间：baseline
The GAD-7 (General Anxiety Disorder-7) measures severity of anxiety over a 2 week period. Answers are scored from 0 to 3 ("not at all" = 0, "several days" = 1, "more than half the days" = 2, and "nearly every day"=3). A score of 10 or higher is considered positive for anxiety.
baseline
Patient Health Questionnaire-9 (PHQ-9)
大体时间：baseline and weeks 1, 12, 24
The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. Nine questions indicate how often the symptom occurred over a 2-week period. A score of 10 or higher is considered clinically significant.
baseline and weeks 1, 12, 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Massachusetts, Worcester

合作者

Emory University

调查人员

  • 首席研究员：Sarah K Whitley, MD, PhD、UMass Chan Medical School

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2029年4月1日

研究注册日期

首次提交

2026年8月4日

首先提交符合 QC 标准的

2026年8月4日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年9月10日

上次提交的符合 QC 标准的更新

2026年9月8日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STUDY00003339
  • 1R61AR087105-01A1 (其他赠款/资助编号：NIAMS/NIH)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Research team will share data and samples from this study with other investigators who are interested in skin diseases, but in that case no patient identifying information will be shared.

IPD 共享时间框架

starting at time of publication of results, ending 7 years following study endpoint

IPD 共享访问标准

Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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