Botulinum Toxin-A for Hidradenitis Suppurativa

Yale University

Status and phase: Withdrawn; Phase 4

Conditions: Hidradenitis Suppurativa, Acne Inversa; Hidradenitis Suppurativa; Hidradenitis Suppurativa \(HS\)

Treatments: Drug: Botulinum toxin type A; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT06237465

2000034975

000

Details and patient eligibility

About

The purpose of this research study is to determine if the medication Botulinum Toxin-A (BTX-A) is effective in treating hidradenitis suppurativa (HS)

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

During their treatment visit, subjects will receive Botulinum Toxin-A in one axillae and normal saline in the other, in a double-blinded fashion.

Treatment:

Drug: Botulinum toxin type A

Placebo Comparator

Placebo Comparator group

Description:

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.

Treatment:

Drug: Normal saline