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Hidradenitis Suppurativa (HS)NCT07755670

Exploration of Brain Functional Networks in Patients With Hidradenitis Suppurativa Using fMRI

An observational study of Hidradenitis Suppurativa (HS), run by Second Xiangya Hospital of Central South University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to learn whether adults with hidradenitis suppurativa (HS) have changes in resting brain activity and how these changes are related to disease severity, pain, sleep, mood, and quality of life. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Hidradenitis Suppurativa (HS)
What is being tested?
Routine Biologic Therapy for Hidradenitis Suppurativa
How many people
80 participants
Where
1 siteChina
Study dates
3 Jan 2026to Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population will include adults with hidradenitis suppurativa evaluated at the Department of Dermatology of the Second Xiangya Hospital of Central South University and age- and sex-matched healthy participants without hidradenitis suppurativa or other chronic skin diseases. Participants with hidradenitis suppurativa will be recruited from the dermatology outpatient population. A subgroup of participants with hidradenitis suppurativa who receive biologic or small-molecule therapy as part of routine clinical care will participate in the 3-month longitudinal follow-up component.

Who may be able to join

  • For Participants With Hidradenitis Suppurativa:
  • Aged 18 to 45 years.
  • Diagnosed with hidradenitis suppurativa according to established clinical diagnostic criteria.
  • Able and willing to comply with the study procedures and follow-up assessments.
  • Able to provide written informed consent and willing to permit photography of affected skin areas.
  • No coexisting systemic lupus erythematosus, dermatomyositis, atopic dermatitis, steroid-dependent dermatitis, or other relevant skin diseases.
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  • No use of biologic or small-molecule therapy that may affect hidradenitis suppurativa symptoms within 3 months before enrollment.
  • Right-handed according to the Edinburgh Handedness Inventory.
  • For Healthy Participants:
  • Aged 18 to 55 years.
  • No hidradenitis suppurativa or other chronic skin disease.
  • No chronic pain disorder.
  • No major neurological or psychiatric disorder.
  • Right-handed according to the Edinburgh Handedness Inventory.
  • Able to provide written informed consent and comply with the study procedures.
  • For the Longitudinal Treatment Cohort:
  • Meets the eligibility criteria for participants with hidradenitis suppurativa.
  • Is scheduled to receive biologic or small-molecule therapy for hidradenitis suppurativa as part of routine clinical care, as determined by the treating physician.
  • Willing and able to complete assessments before treatment and during 3 months of follow-up.

Who cannot join

  • Participation in another investigational drug study within 1 month before enrollment.
  • Alcohol or drug abuse or dependence within the previous 3 months.
  • Current use of medications that may lower the seizure threshold or current use of antidepressant medication.
  • Previous or current treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation.
  • Serious cardiac, hepatic, pulmonary, renal, thyroid, hematologic, or other systemic disease; malignant tumor; or another clinically significant abnormality that, in the investigator's judgment, makes participation inappropriate.
  • Pregnancy or breastfeeding.
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  • Schizophrenia, bipolar disorder, or another major psychiatric disorder.
  • A neurological condition that may interfere with participation or interpretation of the imaging results, including markedly elevated intracranial pressure, intracranial vascular lesions, impaired consciousness, or inability to cooperate with study procedures.
  • Any contraindication to magnetic resonance imaging, including intracranial metallic foreign bodies, cardiac pacemakers, incompatible vascular or cardiac implants, or claustrophobia.
  • Inability to remain still or comply with resting-state functional magnetic resonance imaging procedures.
  • Unwillingness to allow study data to be collected.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

    Yi Zhan, +86-18673121224, misseven69@csu.edu.cn

    Recruiting

Other trials in China

About this study

The goal of this observational study is to learn whether adults with hidradenitis suppurativa (HS) have changes in resting brain activity and how these changes are related to disease severity, pain, sleep, mood, and quality of life. The study will also examine whether brain activity changes after patients receive biologic or small-molecule treatment as part of their regular medical care.

The main questions it aims to answer are:

Read more
  • Are resting brain activity patterns different between people with HS and healthy participants?
  • Are these brain activity patterns related to HS severity, pain, sleep problems, anxiety, depression, and quality of life?
  • Do brain activity patterns change after 3 months of routine treatment, and are these changes related to improvement in HS symptoms? Researchers will compare participants with HS with healthy participants of similar age and sex. A subgroup of participants with HS who receive biologic or small-molecule treatment as part of routine clinical care will also be assessed before and after treatment.

Participants may:

  • Complete assessments of HS severity, pain, sleep, mood, and quality of life
  • Undergo resting-state functional magnetic resonance imaging
  • Undergo skin ultrasound and routine laboratory testing
  • Allow photographs of affected skin areas to be taken
  • Return for follow-up assessments for up to 3 months
Being tested
Routine Biologic Therapy for Hidradenitis Suppurativa
Medical subject headings
Hidradenitis Suppurativa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Routine Biologic Therapy for Hidradenitis SuppurativaBiological

    Biologic therapy is prescribed by the treating physician as part of routine clinical care and is not assigned by the study protocol. The study observes changes in clinical outcomes and resting-state brain activity before treatment and during 3 months of follow-up.

Study groups in NCT07755670
Study groupRoleWhat they receive
HS Cross-Sectional CohortAdults with hidradenitis suppurativa who participate in the cross-sectional comparison with healthy participants. They will undergo baseline clinical assessments, questionnaires, skin ultrasound, laboratory testing, and resting-state functional magnetic resonance imaging.
HS Longitudinal Treatment CohortA subgroup of adults with hidradenitis suppurativa who receive biologic or small-molecule therapy as part of routine clinical care. Participants will undergo assessments before treatment and during 3 months of follow-up, including repeat resting-state functional magnetic resonance imaging at month 3.
Receives: Biological: Routine Biologic Therapy for Hidradenitis Suppurativa
Healthy ParticipantsAge- and sex-matched healthy adults without hidradenitis suppurativa, other chronic skin diseases, chronic pain disorders, or major neurological or psychiatric disorders.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline

    Whole-brain amplitude of low-frequency fluctuation (ALFF) values will be derived from resting-state blood-oxygen-level-dependent functional magnetic resonance imaging. ALFF reflects the amplitude of spontaneous low-frequency fluctuations in the blood-oxygen-level-dependent signal. Voxel-wise ALFF values will be compared between participants with hidradenitis suppurativa and healthy participants.

    Measured: At baseline during a single resting-state fMRI visit

  2. Between-Group Difference in Fractional Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline

    Measured: At baseline during a single resting-state fMRI visit

  3. Between-Group Difference in Regional Homogeneity Derived From Resting-State fMRI at Baseline

    Measured: At baseline during a single resting-state fMRI visit

  4. Between-Group Difference in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Baseline

    Measured: Correlations between the mean time series of selected seed regions and predefined brain regions will be calculated and transformed into standardized connectivity values.

Secondary outcomes (4)
  1. Change From Baseline in ALFF Derived From Resting-State fMRI at Month 3

    Measured: Baseline and 3 months after initiation of routine therapy

  2. Change From Baseline in fALFF Derived From Resting-State fMRI at Month 3

    Measured: Baseline and 3 months after initiation of routine therapy

  3. Change From Baseline in ReHo Derived From Resting-State fMRI at Month 3

    Measured: Baseline and 3 months after initiation of routine therapy

  4. Change From Baseline in Seed-Based Functional Connectivity Derived From Resting-State fMRI at Month 3

    Measured: Baseline and 3 months after initiation of routine therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start3 Jan 2026
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07755670
Sponsor's protocol ID
LYF20250311
Status last verified
Aug 2026
First submitted
4 Aug 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kimball AB, Jemec GBE, Alavi A, Reguiai Z, Gottlieb AB, Bechara FG, Paul C, Giamarellos Bourboulis EJ, Villani AP, Schwinn A, Rueff F, Pillay Ramaya L, Reich A, Lobo I, Sinclair R, Passeron T, Martorell A, Mendes-Bastos P, Kokolakis G, Becherel PA, Wozniak MB, Martinez AL, Wei X, Uhlmann L, Passera A, Keefe D, Martin R, Field C, Chen L, Vandemeulebroecke M, Ravichandran S, Muscianisi E. Secukinumab in moderate-to-severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and week 52 results of two identical, multicentre, randomised, placebo-controlled, double-blind phase 3 trials. Lancet. 2023 Mar 4;401(10378):747-761. doi: 10.1016/S0140-6736(23)00022-3. Epub 2023 Feb 3.

    PubMed 36746171
  • Wu H, Dai W, Hong Z, Qin Y, Yang M, Wang B, Liao J. Higher-order sensorimotor circuit of the whole-brain functional network involved in pruritus regulation in atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 May;38(5):873-882. doi: 10.1111/jdv.19691. Epub 2023 Dec 8.

    PubMed 38069553
  • Najafi P, Ben Salem D, Carre JL, Misery L, Dufor O. Functional and anatomical brain connectivity in psoriasis patients and healthy controls: a pilot brain imaging study after exposure to mentally induced itch. J Eur Acad Dermatol Venereol. 2020 Nov;34(11):2557-2565. doi: 10.1111/jdv.16441. Epub 2020 May 19.

    PubMed 32267024
  • Baral P, Udit S, Chiu IM. Pain and immunity: implications for host defence. Nat Rev Immunol. 2019 Jul;19(7):433-447. doi: 10.1038/s41577-019-0147-2.

    PubMed 30874629
  • Grace PM, Hutchinson MR, Maier SF, Watkins LR. Pathological pain and the neuroimmune interface. Nat Rev Immunol. 2014 Apr;14(4):217-31. doi: 10.1038/nri3621. Epub 2014 Feb 28.

    PubMed 24577438
  • Davis KD, Flor H, Greely HT, Iannetti GD, Mackey S, Ploner M, Pustilnik A, Tracey I, Treede RD, Wager TD. Brain imaging tests for chronic pain: medical, legal and ethical issues and recommendations. Nat Rev Neurol. 2017 Oct;13(10):624-638. doi: 10.1038/nrneurol.2017.122. Epub 2017 Sep 8.

    PubMed 28884750
  • van Straalen KR. Chronic Pain in Hidradenitis Suppurativa Explained Through the Process of Central Sensitization. JAMA Dermatol. 2020 Jun 1;156(6):615-616. doi: 10.1001/jamadermatol.2020.0225. No abstract available.

    PubMed 32267476
  • Aarts P, Aitken JJ, van Straalen KR. Prevalence of Central Sensitization in Patients With Hidradenitis Suppurativa. JAMA Dermatol. 2021 Oct 1;157(10):1209-1212. doi: 10.1001/jamadermatol.2021.2918.

    PubMed 34406352
  • Machado MO, Stergiopoulos V, Maes M, Kurdyak PA, Lin PY, Wang LJ, Shyu YC, Firth J, Koyanagi A, Solmi M, Alavi A, Piguet V, Carvalho AF. Depression and Anxiety in Adults With Hidradenitis Suppurativa: A Systematic Review and Meta-analysis. JAMA Dermatol. 2019 Aug 1;155(8):939-945. doi: 10.1001/jamadermatol.2019.0759.

    PubMed 31166590
  • Jemec GB. Clinical practice. Hidradenitis suppurativa. N Engl J Med. 2012 Jan 12;366(2):158-64. doi: 10.1056/NEJMcp1014163. No abstract available.

    PubMed 22236226

Questions about this trial

What is this clinical trial studying?

An observational study of Hidradenitis Suppurativa (HS), run by Second Xiangya Hospital of Central South University at 1 site in China.

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 19 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yanyang Wu (+86-13676781917, wuyanyang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Between-Group Difference in Amplitude of Low-Frequency Fluctuation Derived From Resting-State fMRI at Baseline (time frame: At baseline during a single resting-state fMRI visit). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07755670, which also lists 10 linked publications.

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 10 Aug 2026.

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