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Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort (Early-HS)

2 november 2026 uppdaterad av: Assistance Publique - Hôpitaux de Paris

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

200

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

12 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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 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)
  • 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:

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

  • 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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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.
Övrig: Biological samples and questionnaires
  • Blood sampling
  • Skin biopsy
  • Tape stripping and swabs:
  • Stool self-sampling
  • Quarterly self-administered questionnaires
  • Dedicated protocol visits
Övrig: 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).
Övrig: Analysis of residual skin tissue

e.g. abdominoplasty, breast reduction

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Identification of a combined molecular and microbiological signature associated with Hurley stage I hidradenitis suppurativa
Tidsram: 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)
At inclusion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free survival to Hurley stage II-III
Tidsram: Up to 96 months

Time from HS diagnosis to the date of progression to Hurley stage II-III
Up to 96 months
Incidence rate of progression to Hurley stage II-III
Tidsram: Up to 96 months

expressed per 100 person-years of follow-up
Up to 96 months
Number of newly involved anatomical regions during follow-up
Tidsram: Up to 96 months

Analysis of topographic extension
Up to 96 months
Proportion of patients in need for major surgery (wide excision, extensive deroofing) and survival free of major surgery
Tidsram: Up to 96 months

time from HS diagnosis to the first surgical procedure
Up to 96 months
Change in IHS4 during follow-up
Tidsram: Up to 96 months

absolute and relative change from inclusion at each annual visit
Up to 96 months
Change in HS-PGA during follow-up
Tidsram: Up to 96 months

absolute and relative change from inclusion at each annual visit
Up to 96 months
Rate of inflammatory flares per year of follow-up
Tidsram: Up to 96 months
Up to 96 months
Patient-reported score - Dermatology Life Quality Index
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - HiSQOL
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - VAS
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - HADS/ADRS
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - AUDIT-C
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - IPAQ - Short Form
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - EPICES
Tidsram: Up to 96 months

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.
Up to 96 months
Patient-reported score - Short FFQ
Tidsram: Up to 96 months

Food Frequency Questionnaires
Up to 96 months
Incidence rate of inflammatory and metabolic comorbidities during follow-up
Tidsram: Up to 96 months
Up to 96 months
Molecular and microbiological signatures differentially expressed over time within the same HS patient
Tidsram: Up to 96 months
Up to 96 months
Keratinocyte marker gene expression in skin biopsy and tape stripping
Tidsram: At inclusion
At inclusion

Samarbetspartners och utredare

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Sponsor

Assistance Publique - Hôpitaux de Paris

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 november 2026

Primärt slutförande (Beräknad)

1 november 2029

Avslutad studie (Beräknad)

1 november 2034

Studieregistreringsdatum

Först inskickad

9 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

2 november 2026

Första postat (Faktisk)

6 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • APHP260139

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