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Botulinum Toxin for HS

(Botox in HS Trial)

SK
TL
Overseen ByTerrie LaMarche
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Massachusetts, Worcester
Must be taking: Doxycycline, Minocycline
Must not be taking: Opioids, Steroids, Biologics, others
Disqualifiers: Pregnancy, Neuromuscular disorders, Immunocompromised, others
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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..

Who Is on the Research Team?

SK

Sarah K Whitley, MD, PhD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

This trial is for people aged 13 to 75 with a confirmed or suspected diagnosis of hidradenitis suppurativa (HS) affecting at least two body areas, who have had HS lesions for at least one year and haven't improved enough with antibiotics. Certain medical conditions, recent surgeries, infections, or specific medications may exclude participation.

Inclusion Criteria

Draining tunnel count of <20 at baseline
I have been diagnosed with or may have Hidradenitis Suppurativa.
I am between 14 and 74 years old.
See 5 more

Exclusion Criteria

I am younger than 13 or older than 75 years old.
Pregnant or breastfeeding
I have not had laser or elective surgery in the treatment area in the last 4 weeks.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either placebo or botulinum toxin injections twice over a 6-month period

24 weeks
Visits at baseline, weeks 4, 12, and 24

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Botulinum Toxin A

Trial Overview

The study compares botulinum toxin A injections to placebo in people with HS. Participants are randomly assigned to receive either the active treatment or a placebo to see if botulinum toxin can reduce disease severity and pain over several months.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: botulinum toxinActive Control1 Intervention
Group II: placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials
372
Recruited
998,000+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

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