Botulinum Toxin Therapy in Hidradenitis Suppurativa

Last updated: June 10, 2024
Sponsor: University of Massachusetts, Worcester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Rosacea

Excessive Sweating

Scalp Disorders

Treatment

Botulinum toxin

Clinical Study ID

NCT05403710
STUDY00000805
7K08AR080844-02
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Botulinum toxin
Phase:
Study Start date:
June 07, 2022
Estimated Completion Date:
April 30, 2028

Study 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.

Connect with a study center

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts 01605
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center = Presbyterian Shadyside

    Pittsburgh, Pennsylvania 15261
    United States

    Site Not Available

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