Clinical trial NCT06237465: Botulinum Toxin-A for Hidradenitis Suppurativa
Official title: Botulinum Toxin-A for Hidradenitis Suppurativa
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Hidradenitis Suppurativa
Hidradenitis Suppurativa \(HS\)
Hidradenitis Suppurativa, Acne Inversa
Keywords: hidradenitis suppurativa
Botulinum Toxin-A
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of lesions
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score
timeFrame: baseline, 3 months and 6 months
measure: Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa
timeFrame: 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Guilford
country: United States
facility: Yale Medicine Multispecialty Clinic
state: Connecticut
Study officials:
affiliation: Department: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University
name: Rummana Aslam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.
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.
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.
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.
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.
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.