Botulinum Toxin-A for Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

Botulinum Toxin-A for Hidradenitis Suppurativa

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06237465
• Other study ID #: 2000034975
• Secondary ID: 000
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Jeremy A Goss, MD
• Phone: 475-224-9337
• Email: jeremy.goss[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Description:

Hidradenitis suppurativa (HS) is an auto-inflammatory disorder of apocrine sweat glands which results in painful, draining nodules within hair-bearing skin of the axillae, groin, and perineum. There is no consensus for treatment of HS and neither a medical nor surgical cure exists. Several case reports show potential efficacy of Botulinum Toxin-A (BTX-A) in inducing remission of HS however, these studies are underpowered. The objective of this study is to determine if Botulinum Toxin- A induces regression, remission, or relapse of hidradenitis suppurativa lesions.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Intervention

Drug:
• Normal saline
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.
• Botulinum toxin type A
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.

Locations

Country	Name	City	State
United States	Yale Medicine Multispecialty Clinic	Guilford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score	HiSQOL is a patient-reported outcome measure developed for clinical trials to address disease-specific changes in HR quality of life (HRQOL). The item scores are summed to create a total ranging from 0 to 68, with higher scores indicating more severe impact on HRQOL.	baseline, 3 months and 6 months
Secondary	Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa	Subjects will be clinically evaluated at 3, 6, and 12 months to monitor qualitative and quantitative change in lesions (nodules, abscesses, fistulous tracts) and symptoms (pain, drainage, swelling, and impairment) and duration of change, if any.	3 months, 6 months, 12 months