Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05507125 |
| Other study ID # |
300006000 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 11, 2022 |
| Est. completion date |
August 31, 2026 |
Study information
| Verified date |
August 2023 |
| Source |
University of Alabama at Birmingham |
| Contact |
Nabiha Yusuf |
| Phone |
2059347432 |
| Email |
nabihayusuf[@]uabmc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this protocol is to examine the cytokine profi le of pati ents with
hidradeniti s suppurati va (HS) and idemechanisms responsible for post-transcripti onal
regulati on of these genes. The primary objecti ve is to determinfollowing cytokines linked
to hidradeniti s suppurati va are diff erenti ally expressed in hidradeniti s pati ents
versus controlalso doing a sub-study to determine the eff ect of childhood trauma on HS. The
parti cipati on in the sub-study is opti onal
Description:
Hidradeniti s suppurati va (HS) is a chronic infl ammatory cutaneous disease which involves
the pilosebaceous-apocrwhich typically presents aft er puberty with painful nodules and
abscesses which can form sinus tracts and scars in theapocrine gland-bearing sites of the
body. 1 Esti mates of disease prevalence range from 0.0003% to 4%, with youngparti cularly
women as the most eff ected group. Racial predilecti on has also been demonstrated, with a
higher likeldisease in African American and biracial individuals when compared to whites.1 HS
is an under-recognized enti ty, ontaking 7.2 years from symptom onset to formal diagnosis.2 A
notable aspect of HS is the profound impact it can have oof life in pati ent's suff ering
with the disease, with an increase in depression, pain, and social and work
impairment.pathogenesis conti nues to be elucidated but is primarily thought to be due to
follicular hyperkeratosis, leading formati on, dilati on, and rupture. This in turn causes
infl ammati on, abscess and sinus tract formati on. 1, 4 Whiunderstanding of a role of tumor
necrosis factor (TNF) alpha, interleukin (IL)-1, IL-17A, IL-23, C-reacti ve protein
(Cinterferon (IFN) gamma have been previously shown, much is sti ll unknown of the molecular
involvement of infl ammarkers in HS.1, 2, 4. Currently, management varies from topical
treatment, to surgical excision, to prescribing manbiologic medicati ons used for hidradeniti
s suppurati va and infl ammatory bowel disease. However, there can be vasvariability in
response to these medicati ons, and a proper understanding of the infl ammatory markers
involved inpathogenesis will allow for more specifi c treatment, while hopefully avoiding the
adverse eff ects related to these isuppressive medicati ons. Thus, in this study we will
assess the cytokines, TNF-alpha, IFN-gamma, IFN-alpha, IFN-beta, IIL-12, IL-23, IL-17A, and
study their regulati on in HS lesions of pati ents, with the ulti mate goal of identi fying
potenti al tafuture therapies and interventi ons.
