NCT05507125

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Oct 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Oct 2022Aug 2028

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 7, 2026

Status Verified

August 1, 2025

Enrollment Period

4.9 years

First QC Date

August 16, 2022

Last Update Submit

August 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Inflammatory biomarkers

    Inflammatory biomarkers

    24 hours after application

Secondary Outcomes (1)

  • Cytokines

    24 hours after application

Study Arms (2)

Control

Participants without inflammatory skin disease

Behavioral: Mental health

Patients with HS

Patients with HS

Behavioral: Mental health

Interventions

Mental healthBEHAVIORAL

Early life exposure to abuse and development of hidradenitis suppurativa

ControlPatients with HS

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Diagnosed with hidradenitis suppurativa
  • Not Pregnant

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Whitaker Clinic

Birmingham, Alabama, 35294, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Mental Health

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Intervention Hierarchy (Ancestors)

HealthPopulation Characteristics

Study Officials

  • Nabiha Yusuf

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

October 11, 2022

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

August 7, 2026

Record last verified: 2025-08

Locations