NCT06237465

Botulinum Toxin-A for Hidradenitis Suppurativa

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hidradenitis Suppurativa
• Hidradenitis Suppurativa \(HS\)
• Hidradenitis Suppurativa, Acne Inversa

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-06-01
• Completion: 2026-01-01
• First posted: 2024-02-01
• Last updated: 2025-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study