Not yet taking people in United StatesPhase 2

Botulinum toxin A for hidradenitis suppurativa skin disease and pain

Tests botulinum toxin A against placebo in people with hidradenitis suppurativa.

Key facts

Who runs it: University of Massachusetts, Worcester
Where: Worcester, United StatesSee the site
Trial code: NCT07756346
Registry title: Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa
Status: Not yet recruiting
Phase: Phase 2
People taking part: 40 people, planned
Started: Oct 2026
Expected to end: Apr 2029
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Botulinum Toxin A (Allergan, Inc, Irvine CA)
Placebo
Record updated: 10 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with hidradenitis suppurativa (HS), a long-lasting inflammatory skin disease. It tests botulinum toxin injections against placebo (saline) for disease severity and pain.

Age: Older than 13 and younger than 75 years
Sex: All sexes
Disease stage: Diagnosed HS with skin lesions for at least 1 year, in at least two different body areas. At least 5 abscesses and nodules, and fewer than 20 draining tunnels at the start.
Earlier treatment: Oral antibiotics did not work well enough, or HS came back after stopping them. No systemic steroids and no new systemic HS therapy in the 12 weeks before the start. No current anti-IL-17A/F, anti-IL-23, anti-IL-1 biologics, or oral JAK or TYK inhibitors.

Main reasons for not taking part

Pregnant or breastfeeding
History of a nerve-muscle disorder, such as ALS or myasthenia gravis
Weak immune system, or active infection in the treatment area
COVID-19 infection now or within 4 weeks before the start
Known allergy to botulinum toxin A or its components

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

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
inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics
abscess and nodule (AN) count ≥ 5 at baseline
draining tunnel count of <20 at baseline
ability to provide written informed consent and/or assent

Who cannot take part

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
use of opioid or non-opioid oral analgesics within 14 days of baseline visit (exception: at a stable dose for at least 14 days prior to baseline)
receiving anti-IL-17A/F, anti-IL-23, or anti-IL-1 biologic therapy or oral JAK inhibitor, TYK inhibitor
active COVID-19 infection or history of COVID-19 infection within 4 weeks prior to baseline
oral or IV antibiotic use during the treatment period (exception: stable dose of doxycycline or minocycline upto 100mg PO BID for 28 days prior to baseline and throughout the 6 month treatment and observation period
initiation of topical therapies for HS within 14 days or baseline visit (may continue stable use of topical therapies started > 14 days prior to baseline visit), -laser surgery, laser hair removal, or elective surgery to treatment areas within 4 weeks prior to baseline visit
current participation in another clinical study involving the administration of an investigative drug for the treatment of HS, or prior participation in such a study within 60 days prior to baseline visit,
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
active bacterial, fungal, or viral infection in the treatment area at baseline visit, -immunocompromised state
known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)
pregnant or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 13 and 75 years old?

Where in United States

UMass Chan Medical SchoolWorcester, United StatesContact: Deborah WhiteNot yet recruiting

About the trial

What the trial wants to find out

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..

The 2 groups in the trial

placeboPlacebo, for comparison
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
botulinum toxinExisting treatment, for comparison
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
Treatment: Botulinum Toxin A (Allergan, Inc, Irvine CA)