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Botulinum Toxin-A for Hidradenitis Suppurativa

NCT06237465 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-12-16

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Normal saline

Thirty subjects with active bilateral axillary hidradenitis suppurativa will be consecutively enrolled and randomly stratified into two groups (Group 1 and Group 2). Both groups will contain five subjects each with mild, moderate, and severe disease. All participants will have 50-units of Botulinum Toxin-A (BTX-A) injected intradermally in one axilla and normal saline (NS) placebo administered in the other in a randomized, double-blinded fashion. At three months, Group 1 will receive 50-units BTX-A and NS in the same axillae as before while Group 2 will receive NS in both axillae.

DRUG

Botulinum toxin type A

Thirty subjects with active bilateral axillary hidradenitis suppurativa will be consecutively enrolled and randomly stratified into two groups (Group 1 and Group 2). Both groups will contain five subjects each with mild, moderate, and severe disease. All participants will have 50-units of Botulinum Toxin-A (BTX-A) injected intradermally in one axilla and normal saline (NS) placebo administered in the other in a randomized, double-blinded fashion. At three months, Group 1 will receive 50-units BTX-A and NS in the same axillae as before while Group 2 will receive NS in both axillae.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Rummana Aslam, MD · Department: Orthopedics and Rehabilitation, Yale New Haven Hospital, Yale School of Medicine, Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-06-30
Completion
2026-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237465 on ClinicalTrials.gov