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Neurotoxin

Botulinum Toxin-A for Hidradenitis Suppurativa

Phase 4
Waitlist Available
Led By Rummana Aslam, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Agreement to forego other treatments for hidradenitis for the duration of the study
Subjects with active axillary hidradenitis suppurativa of the same severity bilaterally
Must not have
Current use of antibiotics, hormonal therapies, steroids, and/or biologics
Known hyperhidrosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months, 12 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to find out if the medication Botulinum Toxin-A (BTX-A) works well in treating hidradenitis suppurativa (HS).

Who is the study for?
This trial is for individuals with hidradenitis suppurativa (HS), a chronic skin condition. Specific eligibility criteria are not provided, but typically participants must have a confirmed diagnosis of HS and meet certain health standards.
What is being tested?
The study is testing the effectiveness of Botulinum Toxin-A (BTX-A) compared to normal saline in treating HS. Participants will receive either BTX-A or a placebo injection to see if there's an improvement in their symptoms.
What are the potential side effects?
Botulinum Toxin-A may cause side effects such as pain at the injection site, muscle weakness, flu-like symptoms, headache, and allergic reactions. The severity can vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to use other hidradenitis treatments during the study.
Select...
I have severe underarm skin conditions on both sides.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking antibiotics, hormones, steroids, or biologic drugs.
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I have been diagnosed with excessive sweating.
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I have a diagnosed neuromuscular disorder.
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I do not have active underarm skin infections.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Number of lesions
Secondary study objectives
Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa
Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score

Side effects data

From 2016 Phase 4 trial • 42 Patients • NCT02321436
7%
Head injury
7%
Insomnia
4%
Pain
4%
Asthma
4%
Tachycardia
4%
Constipation
4%
Pyrexia
4%
Cough
4%
Hypertensive crisis
4%
Pneumonia
4%
Vomiting
4%
Fall
4%
Hypokalaemia
4%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dysport ® 500 U
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
During their treatment visit, subjects will receive Botulinum Toxin-A in one axillae and normal saline in the other, in a double-blinded fashion.
Group II: Placebo ComparatorPlacebo Group1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum toxin type A
2011
Completed Phase 4
~2730

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,924 Previous Clinical Trials
3,031,652 Total Patients Enrolled
Rummana Aslam, MDPrincipal InvestigatorDepartment: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University
2 Previous Clinical Trials
20 Total Patients Enrolled
~7 spots leftby Jan 2025
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