Hidradenitis Suppurativa, Hidradenitis Suppurativa, Acne Inversa, Hidradenitis Suppurativa \(HS\)
Conditions
Keywords
hidradenitis suppurativa, Botulinum Toxin-A
Brief 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)
Detailed description
Hidradenitis suppurativa (HS) is an auto-inflammatory disorder of apocrine sweat glands which results in painful, draining nodules within hair-bearing skin of the axillae, groin, and perineum. There is no consensus for treatment of HS and neither a medical nor surgical cure exists. Several case reports show potential efficacy of Botulinum Toxin-A (BTX-A) in inducing remission of HS however, these studies are underpowered. The objective of this study is to determine if Botulinum Toxin- A induces regression, remission, or relapse of hidradenitis suppurativa lesions.
Interventions
DRUGNormal 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.
DRUGBotulinum 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
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with active axillary hidradenitis suppurativa of the same severity bilaterally. regimen * 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 * Agreement to forego other treatments for hidradenitis for the duration of the study
Exclusion criteria
* Current use of antibiotics, hormonal therapies, steroids, and/or biologics * Presence of cardiac pacemaker * Pregnancy or lactation * Known neuromuscular disorder * Known hyperhidrosis * Febrile illness within one month * Treatment with another investigational drug or other intervention within three months * Patients without active axillary hidradenitis suppurativa
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of lesions | baseline and 3 months | Change in number of lesions (nodules, abscesses, and fistulous tracts). Any changes in lesion count or size will be documented and subjective symptoms such as pain will be noted. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hidradenitis Suppurativa Quality of Life (HiSQOL) score | baseline, 3 months and 6 months | HiSQOL is a patient-reported outcome measure developed for clinical trials to address disease-specific changes in HR quality of life (HRQOL). The item scores are summed to create a total ranging from 0 to 68, with higher scores indicating more severe impact on HRQOL. |
| Change in Duration of Effect of BTX-A in Hidradenitis Suppurativa | 3 months, 6 months, 12 months | Subjects will be clinically evaluated at 3, 6, and 12 months to monitor qualitative and quantitative change in lesions (nodules, abscesses, fistulous tracts) and symptoms (pain, drainage, swelling, and impairment) and duration of change, if any. |
Countries
United States
Outcome results
None listed