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

NCT07756346 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: STUDY000033391R61AR087105-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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..

Conditions

Hidradenitis Suppurativa (HS)

Keywords

botulinum toxin; Botox; ultrasound; tunnel area; mechanistic

Outcome Measures

Primary Outcomes (3)

• percent change from baseline in abscess and inflammatory nodule (AN) count and draining tunnel (dT) count

  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

  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

  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

Secondary Outcomes (13)

• Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)

  baseline and weeks 1, 12 ,24

• Central sensitization Index

  baseline and weeks 1, 12, 24

• Numeric Rating Scale -30

  baseline and weeks 1, 12, 24

• Hidradenitis Suppurativa Clinical Response (HiSCR)-50

  baseline and weeks 1, 12, 24

• Hidradenitis Suppurativa Physician Global Assessment (HS-PGA)

  baseline and weeks 1, 12, 24

Study Arms (2)

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

botulinum toxin

ACTIVE COMPARATOR

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

Drug: Botulinum Toxin A (Allergan, Inc, Irvine CA)

Interventions

Botulinum Toxin A (Allergan, Inc, Irvine CA) DRUG

50U per axilla in 10 injections of 0.1mL

botulinum toxin

Placebo DRUG

10 injections of 0.1mL of normal saline vehicle per laterality

Also known as: saline

placebo

Eligibility Criteria

• Age: 13 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age \>13 and \<75, 2) established or suspected diagnosis of Hidradenitis Suppurativa, 2) HS skin lesions of duration at least 1 year, 3) HS lesions in at least two distinct body areas, 4) inadequate response to a trial of an oral antibiotic or exhibited recurrence after discontinuation of antibiotics, 5) abscess and nodule (AN) count ≥ 5 at baseline, 6) draining tunnel count of \<20 at baseline, and 7) ability to provide written informed consent and/or assent.

You may not qualify if:

• \) Age\<13 or \>75, 2) pregnant or breastfeeding, 3) history of neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy), 4) medical co-morbidity ex. end stage congestive heart failure or coagulopathy that is a relative contradiction to skin biopsy procedure, 5) 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, 6) 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), 7) receiving anti-IL-17A/F, anti-IL-23, or anti-IL-1 biologic therapy or oral JAK inhibitor, TYK inhibitor, 8) active COVID-19 infection or history of COVID-19 infection within 4 weeks prior tobaseline, 9) 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), 10) 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), 11) laser surgery, laser hair removal, or elective surgery to treatment areas within 4 weeks prior to baseline visit, 12) 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, 13) active bacterial, fungal, or viral infection in the treatment area at baseline visit, 14) immunocompromised state, 15) known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate).

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Emory University: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

Related Publications (6)

• 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.

  PMID: 29258169 BACKGROUND

• 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.

  PMID: 26201313 BACKGROUND

• 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.

  PMID: 28612001 BACKGROUND

• 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.

  PMID: 32761500 BACKGROUND

• 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.

  PMID: 34796606 BACKGROUND

• 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.

  PMID: 30693648 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sarah K Whitley, MD, PhD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah K Whitley, MD, PhD

CONTACT

508-856-4086; sarah.whitley@umassmed.edu

Terrie LaMarche

CONTACT

terrie.lamarche@umassmed.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Model Details: Interventional, phase 2, randomized, placebo-controlled clinical trial of botulinum toxin (BoNT) in patients with moderate to severe hidradenitis suppurativa (HS).

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting at time of publication of results, ending 7 years following study endpoint
• Access Criteria: Proposals should be directed to sarah.whitley@umassmed.edu.To gain access to data, requesters will have to sign a data access agreement.

Locations

US (1)