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Targeting Nociceptors in Hidradenitis Suppurativa

Targeting Nociceptors in Hidradenitis Suppurativa

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05403710
Acronym
HS
Enrollment
20
Registered
2022-06-03
Start date
2022-06-07
Completion date
2028-04-30
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa, Hyperhidrosis

Brief summary

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.

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.

Interventions

DRUGBotulinum toxin

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

Sponsors

University of Massachusetts, Worcester
Lead SponsorOTHER
Hidradenitis Suppurativa Foundation
CollaboratorUNKNOWN
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH
AbbVie
CollaboratorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment.1-2 months after first treatmentimmune cell phenotyping

Countries

United States

Contacts

CONTACTSarah K Whitley, MD PhD
sarah.whitley@umassmed.edu(508)856-4086
CONTACTDeborah White, Deborah Peduzzi
deborah.white@umassmed.edu(508)856-2664
PRINCIPAL_INVESTIGATORSarah K Whitley, MD PhD

Assistant Professor of Dermatology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026