Botulinum Toxin-A for Hidradenitis Suppurativa

NCT06237465 | Withdrawn Phase 4 FDA Drug

• 2 other identifiers: 2000034975000
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine if the medication Botulinum Toxin-A (BTX-A) is effective in treating hidradenitis suppurativa (HS)

Conditions

Hidradenitis Suppurativa; Hidradenitis Suppurativa \(HS\); Hidradenitis Suppurativa, Acne Inversa

Keywords

hidradenitis suppurativa; Botulinum Toxin-A

Outcome Measures

Primary Outcomes (1)

• Change in Number of lesions

  Change in number of lesions (nodules, abscesses, and fistulous tracts). Any changes in lesion count or size will be documented and subjective symptoms such as pain will be noted.

  baseline and 3 months

Secondary Outcomes (2)

• Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score

  baseline, 3 months and 6 months

• Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa

  3 months, 6 months, 12 months

Study Arms (2)

Experimental

EXPERIMENTAL

During their treatment visit, subjects will receive Botulinum Toxin-A in one axillae and normal saline in the other, in a double-blinded fashion.

Drug: Botulinum toxin type A

Placebo Comparator

PLACEBO COMPARATOR

At three months, Group 1 subjects will receive 50-units BTX-A and NS in the same axillae as before while Group 2 will receive NS in both axillae.

Drug: Normal saline

Interventions

Normal saline DRUG

Thirty subjects with active bilateral axillary hidradenitis suppurativa will be consecutively enrolled and randomly stratified into two groups (Group 1 and Group 2). Both groups will contain five subjects each with mild, moderate, and severe disease. All participants will have 50-units of Botulinum Toxin-A (BTX-A) injected intradermally in one axilla and normal saline (NS) placebo administered in the other in a randomized, double-blinded fashion. At three months, Group 1 will receive 50-units BTX-A and NS in the same axillae as before while Group 2 will receive NS in both axillae.

Also known as: Placebo

Placebo Comparator

Botulinum toxin type A DRUG

Thirty subjects with active bilateral axillary hidradenitis suppurativa will be consecutively enrolled and randomly stratified into two groups (Group 1 and Group 2). Both groups will contain five subjects each with mild, moderate, and severe disease. All participants will have 50-units of Botulinum Toxin-A (BTX-A) injected intradermally in one axilla and normal saline (NS) placebo administered in the other in a randomized, double-blinded fashion. At three months, Group 1 will receive 50-units BTX-A and NS in the same axillae as before while Group 2 will receive NS in both axillae.

Experimental

Eligibility Criteria

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

You may qualify if:

• Subjects with active axillary hidradenitis suppurativa of the same severity bilaterally. regimen
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation
• Agreement to forego other treatments for hidradenitis for the duration of the study

You may not qualify if:

• Current use of antibiotics, hormonal therapies, steroids, and/or biologics
• Presence of cardiac pacemaker
• Pregnancy or lactation
• Known neuromuscular disorder
• Known hyperhidrosis
• Febrile illness within one month
• Treatment with another investigational drug or other intervention within three months
• Patients without active axillary hidradenitis suppurativa

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Medicine Multispecialty Clinic

Guilford, Connecticut, 06437, United States

Location

Related Publications (9)

• Horowitz LM, Snyder DJ, Boudreaux ED, He JP, Harrington CJ, Cai J, Claassen CA, Salhany JE, Dao T, Chaves JF, Jobes DA, Merikangas KR, Bridge JA, Pao M. Validation of the Ask Suicide-Screening Questions for Adult Medical Inpatients: A Brief Tool for All Ages. Psychosomatics. 2020 Nov-Dec;61(6):713-722. doi: 10.1016/j.psym.2020.04.008. Epub 2020 Apr 28.

  PMID: 32487323 BACKGROUND

• Hua VJ, Kuo KY, Cho HG, Sarin KY. Hyperhidrosis affects quality of life in hidradenitis suppurativa: A prospective analysis. J Am Acad Dermatol. 2020 Mar;82(3):753-754. doi: 10.1016/j.jaad.2019.08.046. Epub 2019 Aug 23. No abstract available.

  PMID: 31449904 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

• Shi W, Schultz S, Strouse A, Gater DR. Successful treatment of stage III hidradenitis suppurativa with botulinum toxin A. BMJ Case Rep. 2019 Jan 20;12(1):e226064. doi: 10.1136/bcr-2018-226064.

  PMID: 30665927 BACKGROUND

• Khoo AB, Burova EP. Hidradenitis suppurativa treated with Clostridium botulinum toxin A. Clin Exp Dermatol. 2014 Aug;39(6):749-50. doi: 10.1111/ced.12380. Epub 2014 Jul 1. No abstract available.

  PMID: 24986398 BACKGROUND

• Feito-Rodriguez M, Sendagorta-Cudos E, Herranz-Pinto P, de Lucas-Laguna R. Prepubertal hidradenitis suppurativa successfully treated with botulinum toxin A. Dermatol Surg. 2009 Aug;35(8):1300-2. doi: 10.1111/j.1524-4725.2009.01231.x. Epub 2009 Jun 3. No abstract available.

  PMID: 19496796 BACKGROUND

• O'Reilly DJ, Pleat JM, Richards AM. Treatment of hidradenitis suppurativa with botulinum toxin A. Plast Reconstr Surg. 2005 Oct;116(5):1575-6. doi: 10.1097/01.prs.0000184354.32111.dc. No abstract available.

  PMID: 16217533 BACKGROUND

• Ravi M, Trinidad J. Botulinum Toxin in Hidradenitis Suppurativa: A Systematic Review. J Drugs Dermatol. 2022 Apr 1;21(4):408-412. doi: 10.36849/JDD.5747.

  PMID: 35389587 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

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Saline Solution; 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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; 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

Study Officials

• Rummana Aslam, MD

  Department: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: January 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)