Botulinum Toxin Therapy in Hidradenitis Suppurativa

NCT05403710 | Recruiting FDA Drug

• 2 other identifiers: STUDY000008057K08AR080844-02
• Study Type: observational
• Target: 20
• 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 test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces pathogenic inflammation.

Conditions

Hidradenitis Suppurativa; Hyperhidrosis

Outcome Measures

Primary Outcomes (1)

• Quantification and phenotyping of skin resident dendritic cell, macrophage, and T cell populations in patients before and after intralesional Botox treatment.

  immune cell phenotyping

  1-2 months after first treatment

Study Arms (1)

single group assignment

men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa

Drug: Botulinum toxin

Interventions

Botulinum toxin DRUG

Administration of botulinum toxin (50 units/100cm2 injected intradermally) into lesional skin

Also known as: Botox

single group assignment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa who will undergo botulinum toxin treatment as part of routine care.

You may qualify if:

• Adults between ages 18 and 75 years with established diagnosis of hidradenitis suppurativa (HS)
• HS skin lesions of duration at least 1 year, HS skin lesions in at least two different body areas

You may not qualify if:

• Age \< 18 years or \> 75 years
• pregnant or breastfeeding
• neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy)
• medical co-morbidity that is a relative contraindication to skin biopsy procedure (ex. end stage congestive heart failure or coagulopathy)
• active bacterial, fungal, or viral infection in the treatment area
• known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)
• prisoners
• adults unable to consent for themselves.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Hidradenitis Suppurativa Foundation: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

RECRUITING

Related Publications (6)

• 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

• 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

• 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

• 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

• 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

• 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

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Formalin fixed paraffin embedded (FFPE) skin specimens will be stored at room temperature in dermatopathology clinical specimen bank in a deidentified manner for upto 5 years. 2. OCT-embedded or snap frozen skin tissue will be stored at -80 degrees celsius in research lab space in a deidentified manner for upto 5 years. 3. RNA derived from skin tissue will be stored at -80 degrees celsius in research lab space in a deidentified manner for upto 5 years.

MeSH Terms

Conditions

Hidradenitis Suppurativa; Hyperhidrosis

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

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)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Sarah K Whitley, MD PhD

  Assistant Professor of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah K Whitley, MD PhD

CONTACT

(508)334-5979; sarah.whitley@umassmed.edu

Michelle Landry, MPH

CONTACT

(508)856-6621; michelle.landry@umassmed.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Dermatology

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: June 3, 2022
• Study Start: June 7, 2022
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: for up to 7 years following data collection
• 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)