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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Whitaker Clinic
Birmingham, Alabama, 35294
Nabiha Yusuf, 2059347432, nabihayusuf@uabmc.edu
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.
- Conditions
- Hidradenitis Suppurativa
- 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 group | Role | What they receive |
|---|---|---|
| Control | Participants without inflammatory skin disease Receives: Behavioral: Mental health | |
| Patients with HS | Patients with HS Receives: Behavioral: Mental health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory biomarkers
Inflammatory biomarkers
Measured: 24 hours after application
Secondary outcomes (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.
- First posted18 Aug 2022
- Study start11 Oct 2022
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabiha Yusuf, University of Alabama at Birmingham
- Investigators
- Nabiha Yusuf, Principal investigator, University of Alabama at Birmingham
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