A Study to Evaluate the Efficacy of Botulinum Toxin in Patients With Hidradenitis Suppurativa

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (HS)

In brief

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..

Key facts

Study ID

NCT07756346

Run by

University of Massachusetts, Worcester

People needed

40

Starts

2026-10-01

Expected to finish

2029-04-01

Last updated by the study team

2026-08-10

Who can join

Age: 13 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• age >13 and <75, 2) established or suspected diagnosis of Hidradenitis Suppurativa, 2) HS skin lesions of duration at least 1 year, 3) HS lesions in at least two distinct body areas, 4) inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics, 5) abscess and nodule (AN) count ≥ 5 at baseline, 6) draining tunnel count of <20 at baseline, and 7) ability to provide written informed consent and/or assent.

You may not qualify if…

• Age<13 or >75, 2) pregnant or breastfeeding, 3) history of neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy), 4) medical co-morbidity ex. end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure, 5) 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, 6) 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), 7) receiving anti-IL-17A/F, anti-IL-23, or anti-IL-1 biologic therapy or oral JAK inhibitor, TYK inhibitor, 8) active COVID-19 infection or history of COVID-19 infection within 4 weeks prior tobaseline, 9) 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), 10) 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), 11) laser surgery, laser hair removal, or elective surgery to treatment areas within 4 weeks prior to baseline visit, 12) 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, 13) active bacterial, fungal, or viral infection in the treatment area at baseline visit, 14) immunocompromised state, 15) known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate).

Where it is running

• UMass Chan Medical School — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.