Botulinum Toxin Therapy in Hidradenitis Suppurativa (HS)

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Hyperhidrosis; Hidradenitis Suppurativa

Treatments: Drug: Botulinum toxin

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05403710

STUDY00000805

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

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

20 participants in 1 patient group

single group assignment

Description:

men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa

Treatment:

Drug: Botulinum toxin