Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05403710

Botulinum Toxin Therapy 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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hidradenitis Suppurativa Bacterial Infections Bacterial Infections and Mycoses Hidradenitis Hyperhidrosis Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin

Drug

Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin

Other names: Botox

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Michelle Landry, MPH

CONTACT

[email protected]

(508)856-6621

Sarah K Whitley, MD PhD

CONTACT

[email protected]

(508)334-5979

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

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

Registry information

Official study title

Targeting Nociceptors in Hidradenitis Suppurativa

Acronym: HS

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2022
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.