NCT07278011

Brief Summary

This observational translational study aims to investigate gene and protein expression in lesional and perilesional skin of patients with Hidradenitis Suppurativa (HS) compared to controls. Skin biopsies were collected from 15 HS patients and 15 age- and sex-matched healthy controls. Gene expression of 15 selected proteins was analyzed using qRT-PCR, while protein levels of 4 targets were assessed by Western blot. The study seeks to identify molecular pathways involved in HS pathogenesis and potential biomarkers for disease severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 6, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 11, 2025

Completed
Last Updated

December 11, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 30, 2025

Last Update Submit

November 30, 2025

Conditions

Keywords

Hidradenitis SuppurativaTAAR1JAKSTATSOCSİnflammation

Outcome Measures

Primary Outcomes (1)

  • Expression levels of TAAR1 and JAK/STAT pathway markers in skin tissue

    To evaluate and compare the gene and protein expression levels of TAAR1 and selected JAK/STAT pathway components in lesion and perilesion skin samples from patients diagnosed with hidradenitis suppurativa and in healthy control skin samples using molecular methods.

    At the time of molecular analysis (September 2025)

Study Arms (3)

HS lesional skin group

Lesional skin biopsy samples were obtained from patients diagnosed with hidradenitis suppurativa. All samples were collected as part of routine clinical evaluation. No treatment interventions were performed as part of the study protocol.

HS perilesional skin group

Perilesional (non-lesional) skin biopsy samples were obtained from patients diagnosed with hidradenitis suppurativa. Samples were collected from areas adjacent to active lesions during routine clinical evaluation. No procedures were performed as part of the study protocol.

Healty control skin group

Skin biopsy samples were obtained from healthy individuals without inflammatory skin disease as a control group. The samples were collected solely for comparative molecular analysis. No intervention for treatment was performed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients aged 18 years and older with a clinical and/or histopathological diagnosis of hidradenitis suppurativa, as well as healthy control individuals aged 18 years and older without autoimmune or inflammatory disease. Healthy controls were selected to be similar to the hidradenitis suppurativa group in terms of age, sex, and metabolic characteristics. Control participants were recruited among individuals presenting for benign nevus excision at the Trakya University Medical Faculty Department of Dermatology.

You may qualify if:

  • Age ≥ 18 years. Ability to read and write. For the patient group: clinical and/or histopathological diagnosis of hidradenitis suppurativa for at least 6 months.
  • No use of topical treatments within the last 2 weeks, conventional systemic treatments within the last 1 month, or biologic therapies within the last 3 months prior to enrollment.
  • Not pregnant at the time of enrollment. Absence of known immunosuppression or malignancy.
  • For the control group: healthy individuals aged ≥18 years without any autoimmune or inflammatory disease, matched to the hidradenitis suppurativa group in terms of age, sex, and metabolic characteristics, who presented for benign nevus excision at the Trakya University Medical Faculty Department of Dermatology.

You may not qualify if:

  • Presence of any autoimmune or inflammatory disease other than hidradenitis suppurativa.
  • Current pregnancy. Known immunosuppression. History of malignancy. Use of topical, systemic conventional, or biologic treatments outside the defined washout periods.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trakya University Medical Faculty, Department of Dermatology

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hidradenitis SuppurativaDermatitisInflammation

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yıldız Gürsel Ürün, MD

    Trakya University

    STUDY CHAIR
  • Zeynep Banu Doğanlar, PhD

    Trakya University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Dermatology Resident

Study Record Dates

First Submitted

November 30, 2025

First Posted

December 11, 2025

Study Start

January 6, 2025

Primary Completion

September 25, 2025

Study Completion

November 21, 2025

Last Updated

December 11, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality considerations and in accordance with the approved ethics committee protocol.

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