Botulinum Toxin Blockade of Neuronal Signals to Immune Cells as a Novel Treatment for Hidradenitis Suppurativa (Botox in HS)
8 de septiembre de 2026 actualizado por: 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..
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Sarah K Whitley, MD, PhD
- Número de teléfono: 508-856-4086
- Correo electrónico: sarah.whitley@umassmed.edu
Copia de seguridad de contactos de estudio
- Nombre: Terrie LaMarche
- Correo electrónico: terrie.lamarche@umassmed.edu
Ubicaciones de estudio
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Massachusetts
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Worcester, Massachusetts, Estados Unidos, 01605
- UMass Chan Medical School
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Contacto:
- Deborah White
- Número de teléfono: (508)856-2664
- Correo electrónico: deborah.white@umassmed.edu
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Contacto:
- Sidney Leno, MD
- Número de teléfono: 714-455-4087
- Correo electrónico: sidney.leno@umassmed.edu
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Investigador principal:
- Sarah K Whitley, MD, PhD
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Sub-Investigador:
- Jessica St. John, MD, MPH
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Sub-Investigador:
- Sidney Leno, MD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: 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
Otros nombres:
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dermatology Quality of Life Index
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sarah K Whitley, MD, PhD, UMass Chan Medical School
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
1 de septiembre de 2028
Finalización del estudio (Estimado)
1 de abril de 2029
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2026
Publicado por primera vez (Actual)
10 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Enfermedades de la piel
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Enfermedades de las glándulas sudoríparas
- Enfermedades De La Piel Bacterianas
- Enfermedades De La Piel Infecciosas
- Supuración
- Hidradenitis
- Enfermedades de la piel y del tejido conectivo
- Hidradenitis supurativa
- Aminoácidos, péptidos y proteínas
- Proteínas
- Factores biológicos
- Hidrolasas
- Enzimas
- Enzimas y coenzimas
- Químicos inorgánicos
- Compuestos de cloro
- Toxinas botulínicas
- Metaloendopeptidasas
- Endopeptidasas
- Hidrolasas peptídicas
- Metaloproteasas
- Proteínas bacterianas
- Toxinas bacterianas
- Toxinas, biológicas
- Compuestos de sodio
- Cloruros
- Ácido clorhídrico
- Toxinas botulínicas tipo A
- Cloruro de sodio
Otros números de identificación del estudio
- STUDY00003339
- 1R61AR087105-01A1 (Otro número de subvención/financiamiento: NIAMS/NIH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
starting at time of publication of results, ending 7 years following study endpoint
Criterios de acceso compartido de IPD
Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .