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Neurotoxin

Experimental 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months, 6 months, 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I agree not to use other hidradenitis treatments during the study.

Select...

I have severe underarm skin conditions on both sides.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months, 6 months, 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Number of lesions

Secondary outcome measures

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

Head injury

Insomnia

Pain

Asthma

Tachycardia

Constipation

Pyrexia

Cough

Hypertensive crisis

Pneumonia

Vomiting

Fall

Hypokalaemia

Urinary tract infection

100%

80%

60%

40%

20%

Study treatment Arm

Dysport ® 500 U

Placebo

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,847 Previous Clinical Trials

2,736,498 Total Patients Enrolled

Rummana Aslam, MDPrincipal InvestigatorDepartment: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University

1 Previous Clinical Trials

10 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to participate in this trial?

"According to the information provided on clinicaltrials.gov, this particular clinical trial is not currently accepting new participants. Although it was initially posted on 1/1/2024 and last updated on 1/23/2024, there are still numerous other studies actively recruiting patients, with a total of 40 ongoing trials available for enrollment."

Answered by AI

What is the level of risk associated with experimental treatments for individuals?

"Given that this trial is classified as Phase 4, indicating that the treatment has already been approved, our team at Power rates its safety level as a 3."

Answered by AI

Recent research and studies

Dermatologic TherapyJournal

Two Cases of Hidradenitis Suppurativa and Botulinum Toxin Type a Therapy: A Novel Approach for a Pathology That Is Still Difficult to Manage

Campanati, Anna, Emanuela Martina, Katia Giuliodori, Ivan Bobyr, Veronica Consales, and Annamaria Offidani. 2019. “Two Cases of Hidradenitis Suppurativa and Botulinum Toxin Type a Therapy: A Novel Approach for a Pathology That Is Still Difficult to Manage”. Dermatologic Therapy. Wiley. doi:10.1111/dth.12841.

clinicaltrials.govStudy

Botulinum Toxin-A for Hidradenitis Suppurativa

2024. "Botulinum Toxin-A for Hidradenitis Suppurativa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06237465.

All > Hidradenitis Suppurativa