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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Other: Biological samples and questionnaires; Other: Analysis of residual skin tissue

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Cassius; Phone Number: +33 01 42 49 99 61; Email: charles.cassius@aphp.fr
• Study Contact Backup: Name: Jérôme Lambert; Phone Number: +33 +33142499742; Email: jerome.lambert@u-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Blood sampling; Skin biopsy; Tape stripping and swabs:; Stool self-sampling; Quarterly self-administered questionnaires; Dedicated protocol visits
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; e.g. abdominoplasty, breast reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	At inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival to Hurley stage II-III	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	expressed per 100 person-years of follow-up	Up to 96 months
Number of newly involved anatomical regions during follow-up	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	time from HS diagnosis to the first surgical procedure	Up to 96 months
Change in IHS4 during follow-up	absolute and relative change from inclusion at each annual visit	Up to 96 months
Change in HS-PGA during follow-up	absolute and relative change from inclusion at each annual visit	Up to 96 months
Rate of inflammatory flares per year of follow-up		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.	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.	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.	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.	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.	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.	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.	Up to 96 months
Patient-reported score - Short FFQ	Food Frequency Questionnaires	Up to 96 months
Incidence rate of inflammatory and metabolic comorbidities during follow-up		Up to 96 months
Molecular and microbiological signatures differentially expressed over time within the same HS patient		Up to 96 months
Keratinocyte marker gene expression in skin biopsy and tape stripping		At inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2034

Study Registration Dates

• First Submitted: October 9, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Patient-reported outcomes; Prognosis factors; Hidradenitis Suppurativa; Pathophysiological mechanisms; Longitudinal outcomes
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: APHP260139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No