Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa (Botox in HS)
8 septembre 2026 mis à jour par: 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..
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
40
Phase
- Phase 2
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Sarah K Whitley, MD, PhD
- Numéro de téléphone: 508-856-4086
- E-mail: sarah.whitley@umassmed.edu
Sauvegarde des contacts de l'étude
- Nom: Terrie LaMarche
- E-mail: terrie.lamarche@umassmed.edu
Lieux d'étude
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Massachusetts
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Worcester, Massachusetts, États-Unis, 01605
- UMass Chan Medical School
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Contact:
- Deborah White
- Numéro de téléphone: (508)856-2664
- E-mail: deborah.white@umassmed.edu
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Contact:
- Sidney Leno, MD
- Numéro de téléphone: 714-455-4087
- E-mail: sidney.leno@umassmed.edu
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Chercheur principal:
- Sarah K Whitley, MD, PhD
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Sous-enquêteur:
- Jessica St. John, MD, MPH
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Sous-enquêteur:
- Sidney Leno, MD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: 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
Autres noms:
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Dermatology Quality of Life Index
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sarah K Whitley, MD, PhD, UMass Chan Medical School
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
1 septembre 2028
Achèvement de l'étude (Estimé)
1 avril 2029
Dates d'inscription aux études
Première soumission
4 août 2026
Première soumission répondant aux critères de contrôle qualité
4 août 2026
Première publication (Réel)
10 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Infections
- Maladies de la peau
- Infections bactériennes
- Infections bactériennes et mycoses
- Maladies des glandes sudoripares
- Maladies de la peau, bactériennes
- Maladies de la peau, infectieuses
- Suppuration
- Hidradénite
- Maladies de la peau et du tissu conjonctif
- Hidrosadénite
- Acides aminés, peptides et protéines
- Protéines
- Facteurs biologiques
- Hydrolases
- Enzymes
- Enzymes et coenzymes
- Produits chimiques inorganiques
- Composés de chlore
- Toxines botuliques
- Métalloenpeptidases
- Endopeptidases
- Hydrolases peptidiques
- Métalloproteases
- Protéines bactériennes
- Toxines bactériennes
- Toxines, biologiques
- Composés de sodium
- Chlorures
- Acide chlorhydrique
- Toxines botuliques, type A
- Chlorure de sodium
Autres numéros d'identification d'étude
- STUDY00003339
- 1R61AR087105-01A1 (Autre subvention/numéro de financement: NIAMS/NIH)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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.
Délai de partage IPD
starting at time of publication of results, ending 7 years following study endpoint
Critères d'accès au partage IPD
Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .