Botulinum Toxin Therapy in Hidradenitis Suppurativa (HS)

September 8, 2025 updated by: Sarah Whitley, University of Massachusetts, Worcester

Targeting Nociceptors in Hidradenitis Suppurativa

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 test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces pathogenic inflammation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Botulinum toxin prevents vesicle fusion at nerve terminals thereby inhibiting neuropeptide release. The investigators will collect punch biopsies of lesional skin from HS patients before, and 1-2 months after botulinum toxin treatment (50U per axilla in 10 injections of 0.1mL) then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if nonselective inhibition of neuropeptide release diminishes IL-17 driven skin inflammation.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa who will undergo botulinum toxin treatment as part of routine care.

Description

Inclusion:

  • Adults between ages 18 and 75 years with established diagnosis of hidradenitis suppurativa (HS)
  • HS skin lesions of duration at least 1 year, HS skin lesions in at least two different body areas

Exclusion:

  • Age < 18 years or > 75 years
  • pregnant or breastfeeding
  • neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy)
  • medical co-morbidity that is a relative contraindication to skin biopsy procedure (ex. end stage congestive heart failure or coagulopathy)
  • active bacterial, fungal, or viral infection in the treatment area
  • known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)
  • prisoners
  • adults unable to consent for themselves.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single group assignment
men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa
Drug: Botulinum toxin
Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin
Other Names:
  • Botox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment.
Time Frame: 1-2 months after first treatment
immune cell phenotyping
1-2 months after first treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease activity
Time Frame: 1-2 months
Evaluation of Hidradenitis Suppurativa Clinical Response (HiSCR), a validated outcome measurement that denotes a 50% reduction in total abscess and nodule count relative to baseline after a treatment
1-2 months
HS-associated pain assessment
Time Frame: 1-2 months
Numerical Rating System of HS-associated pain (NRS; 0-10 where 0= no pain, 10= worst pain possible)
1-2 months
Dermatologic quality of life assessment (SkinDex mini)
Time Frame: 1-2 months
Clinical evaluation of the impact of botulinum toxin treatment on HS-related quality of life. The Skindex mini is divided into a 3 question instrument designed to assess symptoms and their impact on emotions and function. QOL in each domain is scored from 0-6 where a lower score indicates a better QOL.
1-2 months
HS-associated itch assessment
Time Frame: 1-2 months
ItchyQuant (scored 0-10 where 0= no itch, 10= worst itch possible)
1-2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Hidradenitis Suppurativa Foundation

Investigators

  • Principal Investigator: Sarah K Whitley, MD PhD, Assistant Professor of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2022

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

May 16, 2022

First Submitted That Met QC Criteria

May 31, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000805
  • 7K08AR080844-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

for up to 7 years following data collection

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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