HS: Botulinum Toxin Therapy in Hidradenitis Suppurativa
Study Details
Study Description
Brief Summary
This mechanistic observational study will build on data from 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 IL-17 inflammation, relieves pain, and improves quality of life for HS patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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. The investigators will also assess association between skin inflammation and clinical disease activity, HS-associated itch and pain, and HS-associated quality of life.
Study Design
Outcome Measures
Primary Outcome Measures
- Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment. [1-2 months after first treatment]
immune cell phenotyping
Secondary Outcome Measures
- Disease activity [1-2 months]
Evaluation of Hidradenitis Suppurativa Clinical Response (HiSCR), a validated outcome measurement that denotes a 50% reduction in total abscess and nodule count relative to baseline after a treatment
- HS-associated pain assessment [1-2 months]
Numerical Rating System of HS-associated pain (NRS; 0-10 where 0= no pain, 10= worst pain possible)
- Dermatologic quality of life assessment (SkinDex mini) [1-2 months]
Clinical evaluation of the impact of botulinum toxin treatment on HS-related quality of life. The Skindex mini is divided into a 3 question instrument designed to assess symptoms and their impact on emotions and function. QOL in each domain is scored from 0-6 where a lower score indicates a better QOL.
- HS-associated itch assessment [1-2 months]
ItchyQuant (scored 0-10 where 0= no itch, 10= worst itch possible)
Eligibility Criteria
Criteria
Inclusion Criteria:
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age between 18-75
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established or suspected diagnosis of HS
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HS skin lesions of duration at least 1 year
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HS lesions in at least two different body areas
Exclusion Criteria:
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age <18 or >75
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pregnant or breastfeeding
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medical co-morbidity, for example end stage congestive heart failure or coagulopathy, that is a relative contradiction to skin biopsy procedure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Pittsburgh Medical Center = Presbyterian Shadyside | Pittsburgh | Pennsylvania | United States | 15261 |
Sponsors and Collaborators
- Sarah Whitley
- Hidradenitis Suppurativa Foundation
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
- Principal Investigator: Sarah K Whitley, MD PhD, Assistant Professor of Dermatology
Study Documents (Full-Text)
None provided.More Information
Publications
- Campanati A, Martina E, Giuliodori K, Bobyr I, Consales V, Offidani A. Two cases of Hidradenitis suppurativa and botulinum toxin type a therapy: A novel approach for a pathology that is still difficult to manage. Dermatol Ther. 2019 May;32(3):e12841. doi: 10.1111/dth.12841. Epub 2019 Feb 10.
- Campanati A, Martina E, Giuliodori K, Consales V, Bobyr I, Offidani A. Botulinum Toxin Off-Label Use in Dermatology: A Review. Skin Appendage Disord. 2017 Mar;3(1):39-56. doi: 10.1159/000452341. Epub 2017 Feb 1. Review.
- Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6.
- Grimstad Ø, Kvammen BØ, Swartling C. Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. Am J Clin Dermatol. 2020 Oct;21(5):741-748. doi: 10.1007/s40257-020-00537-9.
- Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1:S17-24. Epub 2005 Dec 1. Review.
- Kim YS, Hong ES, Kim HS. Botulinum Toxin in the Field of Dermatology: Novel Indications. Toxins (Basel). 2017 Dec 16;9(12). pii: E403. doi: 10.3390/toxins9120403. Review.
- Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, Teixeira HD, Jemec GB. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):989-94. doi: 10.1111/jdv.13216. Epub 2015 Jul 22.
- Shih T, Lee K, Seivright JR, De DR, Shi VY, Hsiao JL. Hyperhidrosis treatments in hidradenitis suppurativa: A systematic review. Dermatol Ther. 2022 Jan;35(1):e15210. doi: 10.1111/dth.15210. Epub 2021 Nov 30. Review.
- STUDY21090088