Regulation of Inflammatory Genes in Hidradenitis Suppurativa

August 5, 2026 updated by: Nabiha Yusuf, University of Alabama at Birmingham
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • Diagnosed with hidradenitis suppurativa
  • Not Pregnant

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Participants without inflammatory skin disease
Behavioral: Mental health
Early life exposure to abuse and development of hidradenitis suppurativa
Patients with HS
Behavioral: Mental health
Early life exposure to abuse and development of hidradenitis suppurativa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory biomarkers
Time Frame: 24 hours after application
Inflammatory biomarkers
24 hours after application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokines
Time Frame: 24 hours after application
Cytokines
24 hours after application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Nabiha Yusuf, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2022

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 16, 2022

First Posted (Actual)

August 18, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 5, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300006000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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