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| ID | Type | Description | Link |
|---|---|---|---|
| 7K08AR080844-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Hidradenitis Suppurativa Foundation | UNKNOWN |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single group assignment | men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin | Drug | Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment. | immune cell phenotyping | 1-2 months after first treatment |
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Inclusion:
Exclusion:
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The study population will consist of men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa who will undergo botulinum toxin treatment as part of routine care.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah K Whitley, MD PhD | Contact | (508)334-5979 | sarah.whitley@umassmed.edu | |
| Michelle Landry, MPH | Contact | (508)856-6621 | michelle.landry@umassmed.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sarah K Whitley, MD PhD | Assistant Professor of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Chan Medical School | Recruiting | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30693648 | Background | 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. | |
| 34796606 | Background | 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. |
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Research team will share data and samples from this study with other investigators who are interested in skin diseases, but in that case no patient identifying information will be shared.
for up to 7 years following data collection
Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| D006945 | Hyperhidrosis |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| 32761500 | Background | Grimstad O, Kvammen BO, 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. |
| 28612001 | Background | 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. |
| 26201313 | Background | 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. |
| 29258169 | Background | Kim YS, Hong ES, Kim HS. Botulinum Toxin in the Field of Dermatology: Novel Indications. Toxins (Basel). 2017 Dec 16;9(12):403. doi: 10.3390/toxins9120403. |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |