Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa
University of Massachusetts, Worcester
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 extend data from a 12-week pilot study to rigorously test the hypothesis that botulinum toxin (BoNT) therapy reduces disease severity and relieves HS pain symptoms..
Description
We will recruit 40 HS patients with an abscess and inflammatory nodule (AN) count ≥5 at a single body site (ex. bilateral axillae, medial thighs). Participants will be randomized 1:1 to receive placebo or 50U of BoNT per 100cm2 of skin (100U total) administered twice over a 6-month study period. Randomization will be stratified by disease stage (Hurley stage \<III, III). At baseline and weeks 4, 12, and 24 we will measure disease activity and pain symptom burden using percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count as the primary outcom…
Eligibility
- Age range
- 13–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1\) age \>13 and \<75, 2) established or suspected diagnosis of Hidradenitis Suppurativa, 2) HS skin lesions of duration at least 1 year, 3) HS lesions in at least two distinct body areas, 4) inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics, 5) abscess and nodule (AN) count ≥ 5 at baseline, 6) draining tunnel count of \<20 at baseline, and 7) ability to provide written informed consent and/or assent. Exclusion Criteria: 1\) Age\<13 or \>75, 2) pregnant or breastfeeding, 3) history of neuromuscular disorder…
Interventions
- DrugBotulinum Toxin A (Allergan, Inc, Irvine CA)
50U per axilla in 10 injections of 0.1mL
- DrugPlacebo
10 injections of 0.1mL of normal saline vehicle per laterality
Location
- UMass Chan Medical SchoolWorcester, Massachusetts