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

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT07756346
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hidradenitis Suppurativa (HS)

Eligibility Criteria

Sex
ALL
Age
13 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Botulinum Toxin A (Allergan, Inc, Irvine CA) — DRUG
    50U per axilla in 10 injections of 0.1mL
  • Placebo — DRUG
    10 injections of 0.1mL of normal saline vehicle per laterality

Study Details

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 Dates

First listed
Aug 10, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Apr 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: placebo
    Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
  • Active Comparator: botulinum toxin
    Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.

Primary Outcome Measure

percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count [ Time Frame: baseline and weeks 4, 12, and 24 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UMass Chan Medical SchoolWorcesterMassachusetts01605
Deborah White
[email protected]
(508)856-2664
Sidney Leno, MD
[email protected]
714-455-4087
Sarah K Whitley, MD, PhD (PRINCIPAL_INVESTIGATOR)
Jessica St. John, MD, MPH (SUB_INVESTIGATOR)
Sidney Leno, MD (SUB_INVESTIGATOR)

Find similar trials in Worcester, MA

By research site
UMass Chan Medical School· Worcester, MA

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