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

30 Participants Needed

Trial Summary

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 evidence supports the effectiveness of the drug Botulinum Toxin-A for treating Hidradenitis Suppurativa?

Some studies suggest that Botulinum Toxin-A can help reduce the severity of Hidradenitis Suppurativa, improve quality of life, and is generally well-tolerated, although more research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Is Botulinum Toxin-A safe for use in humans?

Botulinum Toxin-A has been used safely in treating conditions like excessive sweating and has been well-tolerated in patients with hidradenitis suppurativa, although more studies are needed to fully understand its safety and effectiveness for this specific condition. ^{1 2 3 4 6}

How is the drug Botulinum Toxin-A unique for treating hidradenitis suppurativa?

Botulinum Toxin-A is unique for treating hidradenitis suppurativa because it works by blocking nerve signals that cause excessive sweating, which can help reduce inflammation and symptoms in this condition. Unlike traditional treatments, it is injected directly into the skin, offering a novel approach for patients who may not respond well to conventional therapies. ^{7 8 9 10 11}

What is the purpose of this trial?

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

Research Team

Rummana Aslam, MD

Principal Investigator

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

Eligibility Criteria

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

I have been diagnosed with excessive sweating.

I have had a fever within the past month.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Botulinum Toxin in Hidradenitis Suppurativa: A Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The Use of Botulinum Toxin in the Management of Hidradenitis Suppurativa: A Systematic Review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Two cases of Hidradenitis suppurativa and botulinum toxin type a therapy: A novel approach for a pathology that is still difficult to manage. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Hyperhidrosis treatments in hidradenitis suppurativa: A systematic review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A for the management of hidradenitis suppurativa. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Successful treatment of stage III hidradenitis suppurativa with botulinum toxin A. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Alternative Clinical Indications of Botulinum Toxin. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Off-Label Use of Botulinum Toxin in Dermatology-Current State of the Art. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin type A in treatment of bilateral primary axillary hyperhidrosis: randomised, parallel group, double blind, placebo controlled trial. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Novel cutaneous uses for botulinum toxin type A. [2010]

11. France pubmed.ncbi.nlm.nih.gov

[Botulinum toxin in disabling dermatological diseases]. [2010]