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RecruitingNCT05403710HSUpdated Sep 10, 2026

Targeting Nociceptors in Hidradenitis Suppurativa

An observational study in Hidradenitis Suppurativa and Hyperhidrosis, sponsored by University of Massachusetts, Worcester. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by University of Massachusetts, Worcester · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Hidradenitis Suppurativa
  • Hyperhidrosis
03

In context

Hidradenitis Suppurativa

284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's planned enrollment of 20 is below the median of 170 across 72 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

University of Massachusetts, Worcester is the lead sponsor of 291 studies on the registry; 51 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion:

  • 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 to skin procedure (ex. end stage congestive heart failure or coagulopathy)
  • active bacterial, fungal, or viral infection in the treatment area
  • known to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)
  • prisoners
  • adults unable to consent for themselves.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • single group assignment

    men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa

    Drug: Botulinum toxin

Interventions

  • Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin

    Also known as: Botox

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What researchers measure

Primary outcomes

  1. Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment.

    immune cell phenotyping

    Time frame: 1-2 months after first treatment

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Study locations

1 of 1 sites recruiting
08

References and documents

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 30693648 ↗
  • 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. PubMed 34796606 ↗
  • 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. PubMed 32761500 ↗
  • 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. PubMed 28612001 ↗
  • 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. PubMed 26201313 ↗
  • 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. PubMed 29258169 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: for up to 7 years following data collection

Access criteria: 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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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2022 (actual). Primary completion is estimated for Apr 2028, 70 months after the start.

Of 44 observational studies under Hidradenitis Suppurativa, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 28. This study's planned 70 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2022
First posted
Jun 3, 2022
StartActual
Jun 7, 2022
Primary completionEst.
Apr 30, 2028
CompletionEst.
Apr 30, 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05403710
Responsible party
Sarah Whitley (Assistant Professor of Dermatology, University of Massachusetts, Worcester) — Principal investigator
First posted
Jun 3, 2022
Start date
Jun 7, 2022
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Sarah K Whitley, MD PhD
Contact
sarah.whitley@umassmed.edu
(508)856-4086
Deborah White, Deborah Peduzzi
Contact
deborah.white@umassmed.edu
(508)856-2664
Sarah K Whitley, MD PhD
principal investigator · Assistant Professor of Dermatology

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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