Hidradenitis Suppurativa (HS)Early-HSNCT07920848
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
A study testing Biological samples and questionnaires and Analysis of residual skin tissue in people with Hidradenitis Suppurativa (HS), run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Hidradenitis suppurativa (HS) is a chronic inflammatory disease affecting approximately 1% of the population. Most pathophysiological studies have focused on advanced forms (Hurley II-III), which obscures the initial mechanisms. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Biological samples and questionnaires and Analysis of residual skin tissue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2034
- Phase
- Interventional
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- HS patients:
- Age ≥ 12 years
- Consultation for a recurrent abscess or nodule in an HS area (axillary, inframammary, abdominal, inguinal, perineal, intergluteal and intermammary regions)
- At least one inflammatory lesional area accessible to biopsy outside skin folds and the face. A fold is defined as the area within 1 cm of the crease.
- First episode within the past 12 months
- Free, informed, written and signed consent (adult patient, or holders of parental authority + assent of the minor)
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- Affiliation to a social security scheme
- Controls:
- Healthy control enrolled in the ImmuneSkinBank research protocol coordinated by the same investigating team (IDRC 2024-A00202-45, APHP240183, favourable opinion from CPP Sud-Méditerranée II), who agreed to the reuse of their data and samples for future research.
- Matched to an HS patient on age (by age group) and sex
- Informed about the study by an information notice sent by post
Who cannot join
- HS patients:
- Buttock involvement
- HS-related sinus tracts (Hurley II or III)
- Treatment that may interfere with the course of HS:
- Long-term antibiotic therapy received within the past month
- Immunosuppressive/immunomodulatory treatment within the past 3 months
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- Person under guardianship or curatorship, under judicial protection, or deprived of liberty by judicial or administrative decision
- Patients covered by State Medical Aid (AME)
- Pregnant or breastfeeding women
- Controls:
- Objection to the research
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Physiopathologie précoce de l'hidradénite suppurée et prédiction du Risque de Progression : Cohorte Prospective
Hidradenitis suppurativa (HS) is a chronic inflammatory disease affecting approximately 1% of the population. Most pathophysiological studies have focused on advanced forms (Hurley II-III), which obscures the initial mechanisms. The mean diagnostic delay of 7 to 10 years and the lack of prognostic biomarkers limit early management. Identifying molecular and microbiological alterations as early as Hurley stage I could allow stratification of the risk of progression and support early intervention strategies.
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Biological samples and questionnaires, Analysis of residual skin tissue
- Keywords
- Hidradenitis Suppurativa, Pathophysiological mechanisms, Prognosis factors, Longitudinal outcomes, Patient-reported outcomes
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples and questionnairesOther
- Blood sampling
- Skin biopsy
- Tape stripping and swabs:
- Stool self-sampling
- Quarterly self-administered questionnaires
- Dedicated protocol visits
Analysis of residual skin tissueOther
e.g. abdominoplasty, breast reduction
| Study group | Role | What they receive |
|---|---|---|
| Patients with HS | Other | Adolescent (≥ 12 years) and adult patients with Hurley stage I HS, presenting with a recurrent nodule or abscess (≥ 2 episodes within 12 months) in characteristic locations. Receives: Other: Biological samples and questionnaires |
| Controls | Other | Healthy subjects matched 1:1 on age (by age group) and sex, recruited among plastic surgery patients with residual skin tissue (e.g. abdominoplasty, breast reduction) enrolled in the ImmuneSkinBank protocol coordinated by the same investigating team (IDRC 2024-A00202-45, NCT06599411, APHP240183). Receives: Other: Analysis of residual skin tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa
- Differentially expressed genes and proteins
- Enriched biological pathways involved in keratinisation, pilosebaceous unit biology, and innate and adaptive immunity
- Skin and gut microbiota profiles (alpha/beta diversity, relative abundance of taxa of interest)
Measured: At inclusion
Secondary outcomes (18)
Progression-free survival to Hurley stage II-III
Time from HS diagnosis to the date of progression to Hurley stage II-III
Measured: Up to 96 months
Incidence rate of progression to Hurley stage II-III
expressed per 100 person-years of follow-up
Measured: Up to 96 months
Number of newly involved anatomical regions during follow-up
Analysis of topographic extension
Measured: Up to 96 months
Proportion of patients in need for major surgery (wide excision, extensive deroofing) and survival free of major surgery
time from HS diagnosis to the first surgical procedure
Measured: Up to 96 months
Change in IHS4 during follow-up
absolute and relative change from inclusion at each annual visit
Measured: Up to 96 months
Change in HS-PGA during follow-up
absolute and relative change from inclusion at each annual visit
Measured: Up to 96 months
Rate of inflammatory flares per year of follow-up
Measured: Up to 96 months
Patient-reported score - Dermatology Life Quality Index
The Dermatology Life Quality Index (DLQI) total score ranges from 0 to 30, with higher scores indicating a greater negative impact of the skin disease on quality of life (0-1: no effect; 2-5: small effect; 6-10: moderate effect; 11-20: very large effect; 21-30: extremely large effect).
The Children's Dermatology Life Quality Index (CDLQI) total score ranges from 0 to 30, with higher scores indicating a greater negative impact of the skin disease on the child's quality of life.
Measured: Up to 96 months
Patient-reported score - HiSQOL
The Hidradenitis Suppurativa Quality of Life (HiSQOL) total score ranges from 0 to 68, with higher scores indicating a greater impact of hidradenitis suppurativa on quality of life. Les seuils publiés récemment sont : 0-4 none, 5-14 mild, 15-21 moderate, 22-23 severe, ≥24 very severe.
Measured: Up to 96 months
Patient-reported score - VAS
Pain intensity is assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Up to 96 months
Patient-reported score - HADS/ADRS
The Hospital Anxiety and Depression Scale (HADS) comprises two subscales, HADS-A for anxiety and HADS-D for depression, each ranging from 0 to 21. For each subscale, higher scores indicate greater symptom burden; scores of 0-7 indicate no significant symptoms, 8-10 borderline/doubtful symptoms, and 11-21 probable/significant symptoms.
The Adolescent Depression Rating Scale (ADRS) self-report score ranges from 0 to 10, with higher scores indicating a higher risk of depressive symptoms.
Measured: Up to 96 months
Patient-reported score - AUDIT-C
The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score ranges from 0 to 12, with higher scores indicating greater levels of potentially hazardous alcohol consumption.
Measured: Up to 96 months
Patient-reported score - IPAQ - Short Form
Physical activity is assessed using the International Physical Activity Questionnaire (IPAQ) and expressed in MET-minutes/week; higher values indicate greater physical activity. Physical activity may also be classified as low, moderate or high.
Measured: Up to 96 months
Patient-reported score - EPICES
Socioeconomic deprivation is assessed using the EPICES score, with higher scores indicating greater socioeconomic deprivation; a score ≥30.17 is commonly used to identify socioeconomic deprivation.
Measured: Up to 96 months
Patient-reported score - Short FFQ
Food Frequency Questionnaires
Measured: Up to 96 months
Incidence rate of inflammatory and metabolic comorbidities during follow-up
Measured: Up to 96 months
Molecular and microbiological signatures differentially expressed over time within the same HS patient
Measured: Up to 96 months
Keratinocyte marker gene expression in skin biopsy and tape stripping
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2034 (estimated)
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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective cohort
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920848
- Sponsor's protocol ID
- APHP260139
- Acronym
- Early-HS
- Status last verified
- Nov 2026
- First submitted
- 9 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiopathologie précoce de l'hidradénite suppurée et prédiction du Risque de Progression : Cohorte Prospective
- ClinicalTrials.gov ID
- NCT07920848
- Acronym / sponsor ID
- Early-HS / APHP260139
- Conditions
- Hidradenitis Suppurativa (HS)
- Keywords
- Hidradenitis Suppurativa, Pathophysiological mechanisms, Prognosis factors, Longitudinal outcomes, Patient-reported outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2034 (estimated)
- First posted
- 6 Nov 2026 (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.
Hidradenitis suppurativa (HS) is a chronic inflammatory disease affecting approximately 1% of the population. Most pathophysiological studies have focused on advanced forms (Hurley II-III), which obscures the initial mechanisms. The mean diagnostic delay of 7 to 10 years and the lack of prognostic biomarkers limit early management. Identifying molecular and microbiological alterations as early as Hurley stage I could allow stratification of the risk of progression and support early intervention strategies.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Patients with HS | Other | Other: Biological samples and questionnairesAdolescent (≥ 12 years) and adult patients with Hurley stage I HS, presenting with a recurrent nodule or abscess (≥ 2 episodes within 12 months) in characteristic locations. |
| Controls | Other | Other: Analysis of residual skin tissueHealthy subjects matched 1:1 on age (by age group) and sex, recruited among plastic surgery patients with residual skin tissue (e.g. abdominoplasty, breast reduction) enrolled in the ImmuneSkinBank protocol coordinated by the same investigating team (IDRC 2024-A00202-45, NCT06599411, APHP240183). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 12 years
- Consultation for a recurrent abscess or nodule in an HS area (axillary, inframammary, abdominal, inguinal, perineal, intergluteal and intermammary regions)
- At least one inflammatory lesional area accessible to biopsy outside skin folds and the face. A fold is defined as the area within 1 cm of the crease.
- First episode within the past 12 months
- Free, informed, written and signed consent (adult patient, or holders of parental authority + assent of the minor)
Key exclusion criteria (11 listed)
- Buttock involvement
- HS-related sinus tracts (Hurley II or III)
- Treatment that may interfere with the course of HS:
- Person under guardianship or curatorship, under judicial protection, or deprived of liberty by judicial or administrative decision
- Patients covered by State Medical Aid (AME)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological samples and questionnaires* Blood sampling * Skin biopsy * Tape stripping and swabs: * Stool self-sampling * Quarterly self-administered questionnaires * Dedicated protocol visits | Other | Patients with HS |
| Analysis of residual skin tissuee.g. abdominoplasty, breast reduction | Other | Controls |
Primary outcome
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa
Time frame: At inclusion
* Differentially expressed genes and proteins * Enriched biological pathways involved in keratinisation, pilosebaceous unit biology, and innate and adaptive immunity * Skin and gut microbiota profiles (alpha/beta diversity, relative abundance of taxa of interest)
18 secondary outcomes
Progression-free survival to Hurley stage II-III
Time frame: Up to 96 months
Incidence rate of progression to Hurley stage II-III
Time frame: Up to 96 months
Number of newly involved anatomical regions during follow-up
Time frame: Up to 96 months
Proportion of patients in need for major surgery (wide excision, extensive deroofing) and survival free of major surgery
Time frame: Up to 96 months
Change in IHS4 during follow-up
Time frame: Up to 96 months
Change in HS-PGA during follow-up
Time frame: Up to 96 months
Rate of inflammatory flares per year of follow-up
Time frame: Up to 96 months
Patient-reported score - Dermatology Life Quality Index
Time frame: Up to 96 months
Patient-reported score - HiSQOL
Time frame: Up to 96 months
Patient-reported score - VAS
Time frame: Up to 96 months
Patient-reported score - HADS/ADRS
Time frame: Up to 96 months
Patient-reported score - AUDIT-C
Time frame: Up to 96 months
Patient-reported score - IPAQ - Short Form
Time frame: Up to 96 months
Patient-reported score - EPICES
Time frame: Up to 96 months
Patient-reported score - Short FFQ
Time frame: Up to 96 months
Incidence rate of inflammatory and metabolic comorbidities during follow-up
Time frame: Up to 96 months
Molecular and microbiological signatures differentially expressed over time within the same HS patient
Time frame: Up to 96 months
Keratinocyte marker gene expression in skin biopsy and tape stripping
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Biological samples and questionnaires and Analysis of residual skin tissue in people with Hidradenitis Suppurativa (HS), run by Assistance Publique - Hôpitaux de Paris.
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 11 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Charles Cassius (01 42 49 99 61 ext. +33, charles.cassius@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa (time frame: At inclusion). 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 6 Nov 2026.