Hidradenitis SuppurativaHSNCT05403710
Targeting Nociceptors in Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa and Hyperhidrosis, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hidradenitis Suppurativa, Hyperhidrosis
- What is being tested?
- Botulinum toxin
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 30 Apr 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
Sidney Leno, MD, 774-455-4087, hsresearch@umassmed.edu
Terrie Lamarche, 508-856-5386, terrie.lamarche@umassmed.edu
About this study
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa, Hyperhidrosis
- Being tested
- Botulinum toxin
- Medical subject headings
- Hidradenitis Suppurativa, Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
Also called Botox
Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin
| Study group | Role | What they receive |
|---|---|---|
| single group assignment | men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa Receives: Drug: Botulinum toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment.
immune cell phenotyping
Measured: 1-2 months after first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start7 Jun 2022
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Hidradenitis Suppurativa Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), AbbVie
- Responsible party
- Principal investigator, Sarah Whitley, University of Massachusetts, Worcester
- Investigators
- Sarah K Whitley, MD PhD, Principal investigator, Assistant Professor of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403710
- Sponsor's protocol ID
- STUDY00000805
- Other IDs
- 7K08AR080844-02
- Acronym
- HS
- Status last verified
- Sep 2026
- First submitted
- 16 May 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 30693648Shih 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.
PubMed 34796606Grimstad 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.
PubMed 32761500Campanati 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.
PubMed 28612001Kimball 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.
PubMed 26201313Kim 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.
PubMed 29258169