Molecular Evaluation of TAAR1 and JAK/STAT Pathway in Hidradenitis Suppurativa

November 30, 2025 updated by: Gülden Karakalem, Trakya University

The Investigation of TAAR1 and JAK/STAT Pathway Gene Expression and Protein Levels in Inflamed Skin Tissue Samples From Patients With Hidradenitis Suppurativa

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Hidradenitis suppurativa (HS) is a chronic, recurrent, inflammatory skin disease affecting areas rich in apocrine glands, characterized by painful nodules, abscesses, sinus tracts, and scar formation. Current evidence indicates that dysregulation of immune signaling pathways plays a central role in the pathogenesis of HS. Among these pathways, the JAK/STAT signaling cascade plays a role in the increase of the inflammatory response, while Trace Amine-Associated Receptor 1 (TAAR1), a G protein-coupled receptor, has recently been found to be associated with immune modulation. However, to our knowledge, the role of TAAR1 in HS has not been investigated before.

This observational study aimed to investigate the expression of genes and protein levels associated with the TAAR1 and JAK/STAT signaling pathways in patients with hidradenitis suppurativa. Lesional and perilesional skin biopsies were obtained from patients diagnosed with HS, and skin biopsy samples were obtained from healthy control individuals without inflammatory skin disease. Molecular analyses were performed to evaluate gene expression and protein levels.

The primary objective of the study was to compare the expression patterns of markers associated with the TAAR1 and JAK/STAT pathways between HS lesion skin, perilesion skin, and healthy control skin.

All participants were monitored in accordance with routine clinical practice, and no therapeutic intervention was applied within the scope of the study protocol. The study was conducted in accordance with the principles of the Helsinki Declaration, approved by the local Clinical Research Ethics Committee, and written informed consent was obtained from all participants prior to their inclusion in the study.

It is expected that the findings from this study will contribute to a better understanding of the molecular mechanisms of hidradenitis suppurativa and provide a scientific basis for targeted treatment approaches in the future.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

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

Study Locations

  • Turkey (Türkiye)
      • Edirne, Turkey (Türkiye), 22030
        • Trakya University Medical Faculty, Department of Dermatology

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression levels of TAAR1 and JAK/STAT pathway markers in skin tissue
Time Frame: At the time of molecular analysis (September 2025)
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)

Collaborators and Investigators

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

Sponsor

Trakya University

Investigators

  • Study Chair: Yıldız Gürsel Ürün, MD, Trakya University
  • Study Director: Zeynep Banu Doğanlar, PhD, Trakya University

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)

January 6, 2025

Primary Completion (Actual)

September 25, 2025

Study Completion (Actual)

November 21, 2025

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 30, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/47
  • TÜTF-GOBAEK 2024/367 (Other Identifier: Trakya University Scientific Research Projects Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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