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Not yet recruitingNCT07920848Early-HSUpdated Nov 6, 2026

Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort

An interventional study of Biological samples and questionnaires and Analysis of residual skin tissue in Hidradenitis Suppurativa (HS), sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Non-randomized
Ages
12 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hidradenitis Suppurativa (HS)

Keywords

  • Hidradenitis Suppurativa
  • Pathophysiological mechanisms
  • Prognosis factors
  • Longitudinal outcomes
  • Patient-reported outcomes
03

In context

Hidradenitis Suppurativa

284 studies on the registry are indexed under Hidradenitis Suppurativa; 87 are open to participants now.

This study's planned enrollment of 200 is above the median of 45 across 199 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.

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

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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 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)
  • 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

Exclusion criteria

Exclusion Criteria:

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
    • /immunomodulatory treatment within the past 3 months
  • 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

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Other
    Patients with HS

    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.

    Other: Biological samples and questionnaires

  • Other
    Controls

    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).

    Other: Analysis of residual skin tissue

Interventions

  • OtherBiological samples and questionnaires

    * Blood sampling * Skin biopsy * Tape stripping and swabs: * Stool self-sampling * Quarterly self-administered questionnaires * Dedicated protocol visits

  • OtherAnalysis of residual skin tissue

    e.g. abdominoplasty, breast reduction

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: At inclusion

Secondary outcomes

  1. Progression-free survival to Hurley stage II-III

    Time from HS diagnosis to the date of progression to Hurley stage II-III

    Time frame: Up to 96 months

  2. Incidence rate of progression to Hurley stage II-III

    expressed per 100 person-years of follow-up

    Time frame: Up to 96 months

  3. Number of newly involved anatomical regions during follow-up

    Analysis of topographic extension

    Time frame: Up to 96 months

  4. 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

    Time frame: Up to 96 months

  5. Change in IHS4 during follow-up

    absolute and relative change from inclusion at each annual visit

    Time frame: Up to 96 months

  6. Change in HS-PGA during follow-up

    absolute and relative change from inclusion at each annual visit

    Time frame: Up to 96 months

  7. Rate of inflammatory flares per year of follow-up

    Time frame: Up to 96 months

  8. 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.

    Time frame: Up to 96 months

  9. 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.

    Time frame: Up to 96 months

  10. 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.

    Time frame: Up to 96 months

  11. 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.

    Time frame: Up to 96 months

  12. 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.

    Time frame: Up to 96 months

  13. 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.

    Time frame: Up to 96 months

  14. 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.

    Time frame: Up to 96 months

  15. Patient-reported score - Short FFQ

    Food Frequency Questionnaires

    Time frame: Up to 96 months

  16. Incidence rate of inflammatory and metabolic comorbidities during follow-up

    Time frame: Up to 96 months

  17. Molecular and microbiological signatures differentially expressed over time within the same HS patient

    Time frame: Up to 96 months

  18. Keratinocyte marker gene expression in skin biopsy and tape stripping

    Time frame: At inclusion

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2029, 36 months later.

Of 25 interventional studies with no phase under Hidradenitis Suppurativa, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Nov 6, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 1, 2029
CompletionEst.
Nov 1, 2034
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07920848
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 1, 2029 (estimated)
Completion
Nov 1, 2034 (estimated)
Last update
Nov 6, 2026

Study contacts

Charles Cassius
Contact
charles.cassius@aphp.fr
01 42 49 99 61 ext. +33
Jérôme Lambert
Contact
jerome.lambert@u-paris.fr
+33142499742 ext. +33

Oversight

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

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