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CompletedNCT07278011Updated Dec 11, 2025

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

An observational study in Hidradenitis Suppurativa (HS) and Skin Inflammation, sponsored by Trakya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-11.

Sponsored by Trakya University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hidradenitis Suppurativa (HS)
  • Skin Inflammation

Keywords

  • Hidradenitis Suppurativa
  • TAAR1
  • JAK
  • STAT
  • SOCS
  • İnflammation
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's enrollment of 30 is below the median of 142 across 69 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Trakya University is the lead sponsor of 150 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: At the time of molecular analysis (September 2025)

07

Study locations

1 site
  • Trakya University Medical Faculty, Department of Dermatology
    Edirne, 22030, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality considerations and in accordance with the approved ethics committee protocol.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07278011
Lead sponsor
Trakya University
Responsible party
Gülden Karakalem (MD, Dermatology Resident, Trakya University) — Principal investigator
First posted
Dec 11, 2025
Start date
Jan 6, 2025
Primary completion
Sep 25, 2025
Completion
Nov 21, 2025
Last update
Dec 11, 2025

Study contacts

Yıldız Gürsel Ürün, MD
study chair · Trakya University
Zeynep Banu Doğanlar, PhD
study director · Trakya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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