Botulinum Toxin-A for Hidradenitis Suppurativa

Overseen By Jeremy A Goss, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Yale University

Must not be taking: Antibiotics, Hormonal therapies, Steroids, Biologics

Disqualifiers: Cardiac pacemaker, Pregnancy, Neuromuscular disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Botulinum Toxin-A (BTX-A), known for its use in Botox, can treat hidradenitis suppurativa (HS), a painful skin condition causing lumps and abscesses. Participants will receive BTX-A injections in one armpit and a placebo in the other, enabling researchers to compare results. Suitable candidates for this trial have active HS in both armpits and are willing to pause other treatments during the study. As a Phase 4 trial, this research aims to understand how this FDA-approved treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

Yes, you will need to stop taking antibiotics, hormonal therapies, steroids, and biologics to participate in the trial.

What is the safety track record for Botulinum Toxin-A?

Research has shown that Botulinum Toxin-A (BTX-A) injections may benefit people with hidradenitis suppurativa (HS). In a review of seven studies, 96.8% of patients reported feeling better or experiencing an improved quality of life after receiving BTX-A.

However, while these studies suggest potential benefits, there is limited strong data on the safety of BTX-A specifically for HS. The FDA has approved BTX-A for other uses, indicating it is generally considered safe.

Prospective trial participants should consider this information when deciding. Discuss any concerns with the trial team or your doctor. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for Hidradenitis Suppurativa, like antibiotics and anti-inflammatory medications, Botulinum Toxin-A offers a novel approach by targeting the sweat glands and reducing inflammation through nerve signal inhibition. This toxin, commonly known for its role in cosmetic procedures, can potentially reduce the excessive sweating and inflammation that contribute to the painful lumps and abscesses of the condition. Researchers are excited about Botulinum Toxin-A because it may provide quicker relief and a new avenue for patients who don't respond well to current therapies.

What evidence suggests that Botulinum Toxin-A might be an effective treatment for hidradenitis suppurativa?

Research has shown that Botulinum Toxin-A (BTX-A) can help manage symptoms of hidradenitis suppurativa (HS). In one study, almost 97% of patients who received BTX-A treatment noticed improvement or felt their quality of life improved. Another study found that BTX-A might reduce inflammation by preventing certain cells from releasing substances that cause swelling and pain. BTX-A has also helped with symptoms like pain and pus drainage when used with other HS treatments. Although high-quality clinical data remains limited, these findings suggest BTX-A could be a promising option for relieving HS symptoms. In this trial, participants will receive Botulinum Toxin-A in one axilla and normal saline in the other, allowing researchers to compare the effects directly. ^{1 2 4 5 6}

Who Is on the Research Team?

Rummana Aslam, MD

Principal Investigator

Department: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I have severe underarm skin conditions on both sides.

Exclusion Criteria

I have had a fever within the past month.

I have not taken part in any other clinical trials or experimental treatments in the last three months.

I am currently taking antibiotics, hormones, steroids, or biologic drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Botulinum Toxin-A in one axillae and normal saline in the other in a double-blinded fashion

3 months

1 visit (in-person) for treatment administration

Follow-up

Participants are monitored for changes in lesions and symptoms at 3, 6, and 12 months

12 months

3 visits (in-person) at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Botulinum Toxin-A

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 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 Comparator Placebo Group 1 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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

This systematic review analyzed six studies involving 26 patients to evaluate the safety and effectiveness of botulinum toxin (BTX) for treating hidradenitis suppurativa (HS), revealing a significant reduction in quality of life scores in one randomized control trial.

Overall, the evidence for BTX's effectiveness and safety in HS treatment is limited, highlighting the need for more high-quality clinical studies to better understand its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Botulinum Toxin in the Management of Hidradenitis Suppurativa: A Systematic Review. Geoghegan, L., Rodrigues, R., Harrison, CJ., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9674480/

The Use of Botulinum Toxin in the Management of ...

The effectiveness and safety of BTX in the treatment of HS remain unknown. This systematic review identified a paucity of high-quality clinical ...

2.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jdv.20611

Botulinum toxin type A efficacy on pain and suppuration in ...

In conclusion, this study demonstrated that 'off-label' treatment with BoNTA is effective as an add-on treatment for symptom control in HS ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05403710

Botulinum Toxin Therapy in Hidradenitis Suppurativa (HS)

The study population will consist of men or women between the ages of 18-75 who have an established diagnosis of Hidradenitis Suppurativa who will undergo ...

4.

jddonline.com

jddonline.com/botulinum-toxin-in-hidradenitis-suppurativa-a-systematic-review/

Botulinum Toxin in Hidradenitis Suppurativa: A Systematic ...

Across seven studies, nearly 97% of patients treated with botulinum toxin reported either clinical improvement or enhanced quality of life.

5.

hcplive.com

hcplive.com/view/botulinum-toxin-type-a-effective-as-add-on-symptom-control-hs

Botulinum Toxin Type A Effective as Add-On for Symptom ...

Botulinum toxin type A may reduce inflammation in HS by inhibiting mast cell degranulation, offering potential as an add-on treatment. A ...

6.

jddonline.com

jddonline.com/from-the-vault-botulinum-toxin-in-hidradenitis-suppurativa-a-systematic-review/

Botulinum Toxin in Hidradenitis Suppurativa: A Systematic ...

A focused review of seven studies now reveals that botulinum toxin injections led to clinical improvement or enhanced quality of life in 96.8 ...