Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa (Botox in HS)
8. september 2026 oppdatert av: 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..
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Antatt)
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Sarah K Whitley, MD, PhD
- Telefonnummer: 508-856-4086
- E-post: sarah.whitley@umassmed.edu
Studer Kontakt Backup
- Navn: Terrie LaMarche
- E-post: terrie.lamarche@umassmed.edu
Studiesteder
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Massachusetts
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Worcester, Massachusetts, Forente stater, 01605
- UMass Chan Medical School
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Ta kontakt med:
- Deborah White
- Telefonnummer: (508)856-2664
- E-post: deborah.white@umassmed.edu
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Ta kontakt med:
- Sidney Leno, MD
- Telefonnummer: 714-455-4087
- E-post: sidney.leno@umassmed.edu
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Hovedetterforsker:
- Sarah K Whitley, MD, PhD
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Underetterforsker:
- Jessica St. John, MD, MPH
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Underetterforsker:
- Sidney Leno, MD
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: placebo
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
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10 injections of 0.1mL of normal saline vehicle per laterality
Andre navn:
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Aktiv komparator: botulinum toxin
Participants will be randomized 1:1 to receive placebo (saline) or botulinum toxin injections.
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50U per axilla in 10 injections of 0.1mL
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
Tidsramme: baseline and weeks 4, 12, and 24
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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.
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baseline and weeks 4, 12, and 24
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Microscopy Analyses of Skin Lesions
Tidsramme: baseline and day 7
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The study team will perform punch biopsies of lesions and non-lesional skin and perform direct immunohistochemistry and immunofluoresce microscopy analysis
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baseline and day 7
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Ultrasound monitoring of skin lesions
Tidsramme: baseline and weeks 1, 12, 24
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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).
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baseline and weeks 1, 12, 24
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dermatology Quality of Life Index
Tidsramme: baseline and weeks 1, 12, 24
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Assesses the degree of pain, the number of flares, and the impact on daily life .
Dermatology disease agnostic, not specific for HS
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baseline and weeks 1, 12, 24
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Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)
Tidsramme: baseline and weeks 1, 12 ,24
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Response is defined as at least a 2-point reduction in HS-IGA score relative to baseline.
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baseline and weeks 1, 12 ,24
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Central sensitization Index (CSI)
Tidsramme: baseline and weeks 1, 12, 24
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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.
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baseline and weeks 1, 12, 24
|
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Numeric Rating Scale -30
Tidsramme: baseline and weeks 1, 12, 24
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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.
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baseline and weeks 1, 12, 24
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Hidradenitis Suppurativa Clinical Response (HiSCR)-50
Tidsramme: baseline and weeks 1, 12, 24
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defined as a 50% reduction in inflammatory lesion count (abscesses + inflammatory nodules) with no increase in abscesses or draining fistulas when compared with baseline.
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baseline and weeks 1, 12, 24
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Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)
Tidsramme: baseline and weeks 1, 12, 24
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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
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baseline and weeks 1, 12, 24
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Hidradenitis Suppurativa Quality of Life (HiSQOL)
Tidsramme: baseline and weeks 1, 12, 24
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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.
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baseline and weeks 1, 12, 24
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International Hidradenitis Suppurativa Severity Score (IHS-4)
Tidsramme: baseline and weeks 1, 12, 24
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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.
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baseline and weeks 1, 12, 24
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Hidradenitis Suppurativa Area and Severity Index Revised
Tidsramme: baseline and weeks 1, 12, 24
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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.
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baseline and weeks 1, 12, 24
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Numeric Rating Scale - Itch
Tidsramme: baseline and weeks 1, 12, 24
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rates itch score as 1-10, 10 indicating most severe itch.
similar to NRS pain instrument
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baseline and weeks 1, 12, 24
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PainDETECT
Tidsramme: baseline and weeks 1, 12, 24
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an assessment tool for neuropathic pain.
Scores range from -1 to 38.
A score of 19 or higher indicates neuropathic pain is likely.
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baseline and weeks 1, 12, 24
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Generalized Anxiety Disorder-7 (GAD-7)
Tidsramme: baseline
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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.
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baseline
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Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: baseline and weeks 1, 12, 24
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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.
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baseline and weeks 1, 12, 24
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Sarah K Whitley, MD, PhD, UMass Chan Medical School
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, Teixeira HD, Jemec GB. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016 Jun;30(6):989-94. doi: 10.1111/jdv.13216. Epub 2015 Jul 22.
- Campanati A, Martina E, Giuliodori K, Bobyr I, Consales V, Offidani A. Two cases of Hidradenitis suppurativa and botulinum toxin type a therapy: A novel approach for a pathology that is still difficult to manage. Dermatol Ther. 2019 May;32(3):e12841. doi: 10.1111/dth.12841. Epub 2019 Feb 10.
- Grimstad O, Kvammen BO, Swartling C. Botulinum Toxin Type B for Hidradenitis Suppurativa: A Randomised, Double-Blind, Placebo-Controlled Pilot Study. Am J Clin Dermatol. 2020 Oct;21(5):741-748. doi: 10.1007/s40257-020-00537-9.
- Shih T, Lee K, Seivright JR, De DR, Shi VY, Hsiao JL. Hyperhidrosis treatments in hidradenitis suppurativa: A systematic review. Dermatol Ther. 2022 Jan;35(1):e15210. doi: 10.1111/dth.15210. Epub 2021 Nov 30.
- Campanati A, Martina E, Giuliodori K, Consales V, Bobyr I, Offidani A. Botulinum Toxin Off-Label Use in Dermatology: A Review. Skin Appendage Disord. 2017 Mar;3(1):39-56. doi: 10.1159/000452341. Epub 2017 Feb 1.
- Kim YS, Hong ES, Kim HS. Botulinum Toxin in the Field of Dermatology: Novel Indications. Toxins (Basel). 2017 Dec 16;9(12):403. doi: 10.3390/toxins9120403.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. oktober 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. april 2029
Datoer for studieregistrering
Først innsendt
4. august 2026
Først innsendt som oppfylte QC-kriteriene
4. august 2026
Først lagt ut (Faktiske)
10. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Hudsykdommer
- Bakterielle infeksjoner
- Bakterielle infeksjoner og mykoser
- Svettekjertelsykdommer
- Hudsykdommer, bakteriell
- Hudsykdommer, smittsomme
- Suppuration
- Hidradenitt
- Hud- og bindevevssykdommer
- Hidradenitis Suppurativa
- Aminosyrer, peptider og proteiner
- Proteiner
- Biologiske faktorer
- Hydrolaser
- Enzymer
- Enzymer og koenzymer
- Uorganiske kjemikalier
- Klorforbindelser
- Botulinumtoksiner
- Metalloendopeptidaser
- Endopeptidaser
- Peptidhydrolaser
- Metalloproteaser
- Bakterielle proteiner
- Bakterielle giftstoffer
- Giftstoffer, biologisk
- Natriumforbindelser
- Klorider
- Saltsyre
- Botulinumtoksiner, type A
- Natriumklorid
Andre studie-ID-numre
- STUDY00003339
- 1R61AR087105-01A1 (Annet stipend/finansieringsnummer: NIAMS/NIH)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
starting at time of publication of results, ending 7 years following study endpoint
Tilgangskriterier for IPD-deling
Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .