Hidradenitis Suppurativa (HS)NCT07278011
Molecular Evaluation of TAAR1 and JAK/STAT Pathway in Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa (HS) and Skin Inflammation, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa (HS), Skin Inflammation
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2025to 21 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Medical Faculty, Department of Dermatology
Edirne, 22030
About this study
Official title: 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.
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.
- Conditions
- Hidradenitis Suppurativa (HS), Skin Inflammation
- Keywords
- Hidradenitis Suppurativa, TAAR1, JAK, STAT, SOCS, İnflammation
- Medical subject headings
- Hidradenitis Suppurativa, Dermatitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of molecular analysis (September 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start6 Jan 2025
- Primary completion25 Sep 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülden Karakalem, Trakya University
- Investigators
- Yıldız Gürsel Ürün, MD, Study chair, Trakya UniversityZeynep Banu Doğanlar, PhD, Study director, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278011
- Sponsor's protocol ID
- 2025/47
- Other IDs
- TÜTF-GOBAEK 2024/367
- Status last verified
- Nov 2025
- First submitted
- 30 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations and in accordance with the approved ethics committee protocol.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation of TAAR1 and JAK/STAT Pathway Gene Expression and Protein Levels in Inflamed Skin Tissue Samples From Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT07278011
- Acronym / sponsor ID
- 2025/47
- Conditions
- Hidradenitis Suppurativa (HS), Skin Inflammation
- Keywords
- Hidradenitis Suppurativa, TAAR1, JAK, STAT, SOCS, İnflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations and in accordance with the approved ethics committee protocol.
Related trials for Hidradenitis Suppurativa (HS)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yıldız Gürsel Ürün, MD study chair
Trakya University
Zeynep Banu Doğanlar, PhD study director
Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa (HS) and Skin Inflammation, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression levels of TAAR1 and JAK/STAT pathway markers in skin tissue (time frame: At the time of molecular analysis (September 2025)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.