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Hidradenitis SuppurativaNCT05507125

Regulation of Inflammatory Genes in Hidradenitis Suppurativa

An observational study of Hidradenitis Suppurativa, run by University of Alabama at Birmingham at 1 site in United States.

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Sites and contacts
Official record

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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. Read more about this study

Who is it for?
Ages 18 to 89 years
Conditions the study is for
Hidradenitis Suppurativa
What is being tested?
Mental health
How many people
200 participants
Where
1 siteUnited States
Study dates
11 Oct 2022to 31 Aug 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • Adult, Older adult

Study population: Hidradenitis suppurativa is an autoinflammatory skin disorder.They are difficult-to-heal and often scar. Hidradenitis suppurativa also has a significant psychological impact, and many patients suffer depression, anxiety, and impaired body-image. A hallmark of hidradenitis suppurativa is increased levels of biomarkers, which are molecules found in blood, other body fluids, or tissues that can be a sign of a normal or abnormal process. In hidradenitis suppurativa, these biomarkers are called "cytokines" and their job is to trigger the disease and make it worse.

Who may be able to join

  • Diagnosed with hidradenitis suppurativa
  • Not Pregnant

Who cannot join

  • Mild/general dermatological issues like moles, other cosmetic issues
  • Patients with hidradenitis suppurativa, psoriasis, roasacea, atopic dermatitis and other inflammatory skin disease
  • Pregnant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • Whitaker Clinic

    Birmingham, Alabama, 35294

    Nabiha Yusuf, 2059347432, nabihayusuf@uabmc.edu

    Recruiting

Other trials in United States

About this study

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

Read the detailed 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.

Being tested
Mental health
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mental healthBehavioural

    Early life exposure to abuse and development of hidradenitis suppurativa

Study groups in NCT05507125
Study groupRoleWhat they receive
ControlParticipants without inflammatory skin disease
Receives: Behavioral: Mental health
Patients with HSPatients with HS
Receives: Behavioral: Mental health

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory biomarkers

    Inflammatory biomarkers

    Measured: 24 hours after application

Secondary outcomes (1)
  1. Cytokines

    Cytokines

    Measured: 24 hours after application

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2022
  2. Study start11 Oct 2022
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507125
Sponsor's protocol ID
IRB-300006000
Other IDs
Univ. of Alabama at Birmingham
Status last verified
Sep 2026
First submitted
16 Aug 2022
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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