Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2025-01-31
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Principal Investigators
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Rummana Aslam, MD
Role: PRINCIPAL_INVESTIGATOR
Department: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University
Locations
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Yale Medicine Multispecialty Clinic
Guilford, Connecticut, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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000
Identifier Type: OTHER
Identifier Source: secondary_id
2000034975
Identifier Type: -
Identifier Source: org_study_id