Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

University of Massachusetts Chan Medical School
Worcester, Massachusetts 01605
Contact:
Celia Hartigan, RN
774-455-4756
celia.hartigan@umassmed.edu

More Details

Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Sarah K Whitley, MD PhD
(508)334-5979
sarah.whitley@umassmed.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.