Botulinum Toxin-A for Hidradenitis Suppurativa

Phase 4

Not yet recruiting

• Conditions: Hidradenitis Suppurativa; Hidradenitis Suppurativa, Acne Inversa; Hidradenitis Suppurativa \(HS\)
• Interventions: Drug: Normal saline; Drug: Botulinum toxin type A

• Registration Number: NCT06237465
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2024-01-23
• Study First Submitted QC: 2024-01-23
• Study First Posted: 2024-02-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-06
• Study Start: 2025-01
• Primary Completion: 2025-06
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Normal saline	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.
Experimental	Botulinum toxin type A	During their treatment visit, subjects will receive Botulinum Toxin-A in one axillae and normal saline in the other, in a double-blinded fashion.

Primary Outcome Measures

Name	Time	Method
Change in Number of lesions	baseline and 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score	baseline, 3 months and 6 months	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.
Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa	3 months, 6 months, 12 months	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.

Trial Locations

Locations (1)

Yale Medicine Multispecialty Clinic; 🇺🇸 Guilford, Connecticut, United States