Botulinum Toxin Therapy in Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

— HS  

Official title:

Targeting Nociceptors in Hidradenitis Suppurativa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05403710
• Other study ID #: STUDY21090088
• Status: Recruiting
• Start date: June 7, 2022
• Est. completion date: July 1, 2025

Study information

• Verified date: July 2022
• Source: University of Pittsburgh
• Contact: Sarah K Whitley, MD PhD
• Phone: (205)531-0671
• Email: sarahwhitley[@]pitt.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This mechanistic observational study will build on data from 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 IL-17 inflammation, relieves pain, and improves quality of life for HS patients.

Description:

Botulinum toxin prevents vesicle fusion at nerve terminals thereby inhibiting neuropeptide release. The investigators will collect punch biopsies of lesional skin from HS patients before, and 1-2 months after botulinum toxin treatment (50U per axilla in 10 injections of 0.1mL) then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if nonselective inhibition of neuropeptide release diminishes IL-17 driven skin inflammation. The investigators will also assess association between skin inflammation and clinical disease activity, HS-associated itch and pain, and HS-associated quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2025
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age between 18-75
• established or suspected diagnosis of HS
• HS skin lesions of duration at least 1 year
• HS lesions in at least two different body areas

Exclusion Criteria:

• age <18 or >75
• pregnant or breastfeeding
• medical co-morbidity, for example end stage congestive heart failure or coagulopathy, that is a relative contradiction to skin biopsy procedure

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hyperhidrosis

Intervention

Drug:
• Botulinum toxin
Standard-of-care administration of botulinum toxin (50 units/axilla injected intradermally) will be performed for routine treatment of Hidradenitis Suppurativa

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center = Presbyterian Shadyside	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Sarah Whitley	Hidradenitis Suppurativa Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

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. Review. — View Citation

Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar. — View Citation

Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use. Clin Exp Dermatol. 1994 May;19(3):210-6. — View Citation

Grimstad Ø, Kvammen BØ, 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

Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1:S17-24. Epub 2005 Dec 1. Review. — View Citation

Kim YS, Hong ES, Kim HS. Botulinum Toxin in the Field of Dermatology: Novel Indications. Toxins (Basel). 2017 Dec 16;9(12). pii: E403. doi: 10.3390/toxins9120403. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Disease activity	Evaluation of Hidradenitis Suppurativa Clinical Response (HiSCR), a validated outcome measurement that denotes a 50% reduction in total abscess and nodule count relative to baseline after a treatment	1-2 months
Secondary	HS-associated pain assessment	Numerical Rating System of HS-associated pain (NRS; 0-10 where 0= no pain, 10= worst pain possible)	1-2 months
Secondary	Dermatologic quality of life assessment (SkinDex mini)	Clinical evaluation of the impact of botulinum toxin treatment on HS-related quality of life. The Skindex mini is divided into a 3 question instrument designed to assess symptoms and their impact on emotions and function. QOL in each domain is scored from 0-6 where a lower score indicates a better QOL.	1-2 months
Secondary	HS-associated itch assessment	ItchyQuant (scored 0-10 where 0= no itch, 10= worst itch possible)	1-2 months