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..
Age >13 and <75
established diagnosis of HS
HS skin lesions of duration at least 1 year
HS lesions in at least two distinct body areas
pregnant or breastfeeding
history of neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy
medical co-morbidity ex. end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure
received systemic steroids or started a new systemic (biologic or non-biologic immunomodulator, oral retinoid) therapy with potential therapeutic impact for HS <12 weeks prior to baseline visit
Parallel
Botulinum Toxin A (Allergan, Inc, Irvine CA)
Drug50U per axilla in 10 injections of 0.1mL
Placebo
Drug10 injections of 0.1mL of normal saline vehicle per laterality
percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
All subjects will receive 2 treatments with onabotulinum toxin A OR placebo (saline) 3 months apart, over a 6-month study period. At baseline and at week 12 each patient will receive 50 units of Botox per 100cm2 of skin, injected intradermally in 10 injections of 0.1mL spaced 1 cm apart to one HS-affected body site (ex. bilateral axillae, inguinal, medial thighs, inframammary chest) for a total of 100U per treatment.
Microscopy Analyses of Skin Lesions
The study team will perform punch biopsies of lesions and non-lesional skin and perform direct immunohistochemistry and immunofluoresce microscopy analysis
Ultrasound monitoring of skin lesions
Ultra-high frequency ultrasound (UHFU): This non- invasive imaging technique will be used to quantify HS tunnel area and cutaneous blood flow rate in treatment areas using an established protocol as detailed in Oranges T Skin Res Technology 2020).
Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)
Response is defined as at least a 2-point reduction in HS-IGA score relative to baseline.
Central sensitization Index (CSI)
measures centrally processed pain signals. The participant scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitization.
Numeric Rating Scale -30
The numeric rating scale (NRS) is a pain scale that asks a patient to rate their pain on a scale of 0 to 10 where a higher score indicates a higher pain level. It's a common tool used in healthcare to assess pain severity.
Hidradenitis Suppurativa Clinical Response (HiSCR)-50
defined as a 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules) with no increase in abscesses or draining fistulas when compared with baseline.
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University of Massachusetts, Worcester
Lead sponsor
Emory University
Collaborator
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