Could botox calm the painful skin flares of hidradenitis suppurativa?
NCT ID NCT07756346
First seen Aug 10, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This phase 2 trial tests whether injecting botulinum toxin (Botox) into skin affected by hidradenitis suppurativa (HS) can reduce the number of painful abscesses, nodules, and draining tunnels, and ease pain. About 40 people with HS will receive either Botox or a saline placebo injection twice, three months apart. Researchers will also use skin biopsies and ultrasound to see how the treatment affects the skin and underlying inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Botulinum toxin A (Botox) injected into affected skin areas
- What this could lead to
- If effective, this could offer a new treatment option for hidradenitis suppurativa, reducing painful lesions and improving quality of life.
- What could go wrong
- This is a small, early-stage trial. The treatment may not work for everyone, and there are risks like injection-site reactions or temporary muscle weakness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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13 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * pregnant or breastfeeding * 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 * 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, * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UMass Chan Medical School
Worcester, Massachusetts, 01605, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a daily pill tame the painful lesions of hidradenitis suppurativa?
- Can a new injection quiet the painful lumps of hidradenitis suppurativa?
- Can a new injection tame the painful lumps of hidradenitis suppurativa?