Botulinum Toxin-A for Hidradenitis Suppurativa
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.12345Why 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.12456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Botulinum Toxin-A in one axillae and normal saline in the other in a double-blinded fashion
Follow-up
Participants are monitored for changes in lesions and symptoms at 3, 6, and 12 months
What Are the Treatments Tested in This Trial?
Interventions
- Botulinum Toxin-A
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor