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Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa (Botox in HS)

8 september 2026 bijgewerkt door: Sarah Whitley, University of Massachusetts, Worcester
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..

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study will recruit 40 HS patients with an abscess and inflammatory nodule (AN) count ≥5 at a single body site (ex. bilateral axillae, medial thighs). Participants will be randomized 1:1 to receive placebo or 50U of BoNT per 100cm2 of skin (100U total) administered twice over a 6-month study period. Randomization will be stratified by disease stage (Hurley stage <III, III). At baseline and weeks 4, 12, and 24 disease activity and pain symptom burden will be measured using percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count as primary outcomes and achievement of ≥ 30% reduction from baseline in the Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS)-30 as a secondary outcome. The investigators will conduct high-frequency ultrasound measurement of HS tunnel area at baseline and weeks 4,12, and 24 to determine if BoNT therapy can reduce tunnel size. The study team will also collect punch biopsies of lesional skin from HS patients before, and 4 weeks after BoNT treatment then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if and how nonselective inhibition of neuropeptide release diminishes HS inflammation.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Worcester, Massachusetts, Verenigde Staten, 01605
        • UMass Chan Medical School
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Sarah K Whitley, MD, PhD
        • Onderonderzoeker:
          • Jessica St. John, MD, MPH
        • Onderonderzoeker:
          • Sidney Leno, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: placebo
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
Geneesmiddel: Placebo
10 injections of 0.1mL of normal saline vehicle per laterality
Andere namen:
  • zoutoplossing
Actieve vergelijker: botulinum toxin
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
Geneesmiddel: Botulinum Toxin A (Allergan, Inc, Irvine CA)
50U per axilla in 10 injections of 0.1mL

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
Tijdsspanne: baseline and weeks 4, 12, and 24
All subjects will receive 2 treatments with onabotulinum toxin A OR placebo (saline) 3 months apart, over a 6-month study period. At baseline and at week 12 each patient will receive 50 units of Botox per 100cm2 of skin, injected intradermally in 10 injections of 0.1mL spaced 1 cm apart to one HS-affected body site (ex. bilateral axillae, inguinal, medial thighs, inframammary chest) for a total of 100U per treatment.
baseline and weeks 4, 12, and 24
Microscopy Analyses of Skin Lesions
Tijdsspanne: baseline and day 7
The study team will perform punch biopsies of lesions and non-lesional skin and perform direct immunohistochemistry and immunofluoresce microscopy analysis
baseline and day 7
Ultrasound monitoring of skin lesions
Tijdsspanne: baseline and weeks 1, 12, 24
Ultra-high frequency ultrasound (UHFU): This non- invasive imaging technique will be used to quantify HS tunnel area and cutaneous blood flow rate in treatment areas using an established protocol as detailed in Oranges T Skin Res Technology 2020).
baseline and weeks 1, 12, 24

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dermatology Quality of Life Index
Tijdsspanne: baseline and weeks 1, 12, 24
Assesses the degree of pain, the number of flares, and the impact on daily life . Dermatology disease agnostic, not specific for HS
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)
Tijdsspanne: baseline and weeks 1, 12 ,24
Response is defined as at least a 2-point reduction in HS-IGA score relative to baseline.
baseline and weeks 1, 12 ,24
Central sensitization Index (CSI)
Tijdsspanne: baseline and weeks 1, 12, 24
measures centrally processed pain signals. The participant scores each answer on a scale of 0 (never) to 4 (always). A score of more than 40 indicates the presence of central sensitization.
baseline and weeks 1, 12, 24
Numeric Rating Scale -30
Tijdsspanne: baseline and weeks 1, 12, 24
The numeric rating scale (NRS) is a pain scale that asks a patient to rate their pain on a scale of 0 to 10 where a higher score indicates a higher pain level. It's a common tool used in healthcare to assess pain severity.
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Clinical Response (HiSCR)-50
Tijdsspanne: baseline and weeks 1, 12, 24
defined as a 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules) with no increase in abscesses or draining fistulas when compared with baseline.
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
Tijdsspanne: baseline and weeks 1, 12, 24
The six-point Hidradenitis Suppurativa Physician Global Assessment (PGA) ranges from clear to very severe where a higher score indicates more severe disease. It is used in clinical trials to measure clinical improvement in inflammatory nodules,abscesses and draining fistulae
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Quality of Life (HiSQOL)
Tijdsspanne: baseline and weeks 1, 12, 24
A 17-item questionnaire designed to measure quality of life for people with HS. Scores range from 0-68 where higher scores indicate a worse impact on quality of life.
baseline and weeks 1, 12, 24
International Hidradenitis Suppurativa Severity Score (IHS-4)
Tijdsspanne: baseline and weeks 1, 12, 24
The International Hidradenitis Suppurativa Severity Score (IHS4) is a validated tool that measures the severity of hidradenitis suppurativa (HS). The IHS4 score is calculated by adding the number of nodules, abscesses, and draining tunnels, each multiplied by a weight A score of 3 or less indicates mild HS, 4-10 indicates moderate HS, and 11 or higher indicates severe HS. The IHS4 is used to assess the severity of HS and to measure inflammatory lesions, such as draining tunnels.
baseline and weeks 1, 12, 24
Hidradenitis Suppurativa Area and Severity Index Revised
Tijdsspanne: baseline and weeks 1, 12, 24
The HASI-R method assesses HS severity in a manner that incorporates signs of inflammation and body surface area involved. Scores range from 0-720 where a higher score indicates worse disease.
baseline and weeks 1, 12, 24
Numeric Rating Scale - Itch
Tijdsspanne: baseline and weeks 1, 12, 24
rates itch score as 1-10, 10 indicating most severe itch. similar to NRS pain instrument
baseline and weeks 1, 12, 24
PainDETECT
Tijdsspanne: baseline and weeks 1, 12, 24
an assessment tool for neuropathic pain. Scores range from -1 to 38. A score of 19 or higher indicates neuropathic pain is likely.
baseline and weeks 1, 12, 24
Generalized Anxiety Disorder-7 (GAD-7)
Tijdsspanne: baseline
The GAD-7 (General Anxiety Disorder-7) measures severity of anxiety over a 2 week period. Answers are scored from 0 to 3 ("not at all" = 0, "several days" = 1, "more than half the days" = 2, and "nearly every day"=3). A score of 10 or higher is considered positive for anxiety.
baseline
Patient Health Questionnaire-9 (PHQ-9)
Tijdsspanne: baseline and weeks 1, 12, 24
The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. Nine questions indicate how often the symptom occurred over a 2-week period. A score of 10 or higher is considered clinically significant.
baseline and weeks 1, 12, 24

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Massachusetts, Worcester

Medewerkers

Emory University

Onderzoekers

  • Hoofdonderzoeker: Sarah K Whitley, MD, PhD, UMass Chan Medical School

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2026

Primaire voltooiing (Geschat)

1 september 2028

Studie voltooiing (Geschat)

1 april 2029

Studieregistratiedata

Eerst ingediend

4 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 augustus 2026

Eerst geplaatst (Werkelijk)

10 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 september 2026

Laatste update ingediend die voldeed aan QC-criteria

8 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00003339
  • 1R61AR087105-01A1 (Ander subsidie-/financieringsnummer: NIAMS/NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Research team will share data and samples from this study with other investigators who are interested in skin diseases, but in that case no patient identifying information will be shared.

IPD-tijdsbestek voor delen

starting at time of publication of results, ending 7 years following study endpoint

IPD-toegangscriteria voor delen

Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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