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Could botox calm the painful skin flares of hidradenitis suppurativa?

NCT ID NCT07756346

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

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

13 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • UMass Chan Medical School

    Worcester, Massachusetts, 01605, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.