Botulinum Toxin-A for Hidradenitis Suppurativa

Recruiting in Palo Alto (17 mi)

Overseen byRummana Aslam, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Yale University

Prior Safety Data

Trial Summary

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)

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.

+5 more

Participant Groups

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.

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.