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RecruitingNCT05531747Fol-HydraUpdated Feb 6, 2025

Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa

An interventional study of Skin biopsy and Blood sample in Hidradenitis Suppurativa, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-02-06.

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

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Hidradenitis Suppurativa is a recurrent chronic inflammatory follicular occlusive disease affecting hair follicles. HS is notoriously difficult and challenging to treat with a high morbidity impact and could be classified as an unmet medical need with no efficient therapeutic options.

Objective:

Investigators previously showed that Outer Root Sheath Cells (ORS) isolated from hair follicle of HS patients (HS-ORS) have a pro-inflammatory phenotype and secrete spontaneously IP-10 and RANTES. To identify the mechanisms involved in the pro-inflammatory phenotype of HS-ORS, investigators performed a transcriptomic analysis in healthy and HS patients. This revealed: (i) an IFN signature, (i) a dysregulation of genes involved in cell proliferation and differentiation, and (iii) an upregulation of DNA damage response and cell cycle G2/M checkpoint pathways in HS-ORS. These findings support the notion that, in HS patients, a perturbation of HF-SC homeostasis leading to an increased proliferation induces a replicative stress and an accumulation of cytoplasmic ssDNA, stimulating IFN synthesis through IFI16-STING pathway. Interestingly, replicative stress in ORS were present in some but not all patients with Hidradenitis Suppurativa. The goal of study is to determine replicative stress in ORS in a large cohort of HS patients.

Method Patients will be enrolled in the Mondor Dermatology department, during routine care. A dermatologist will check all inclusion and exclusion criteria with the technical support of a research technician of the Henri Mondor Clinical Investigation Center. Medical history, clinical data, comorbidities and concomitant therapies will be prospectively recorded in a dedicated case report form. Skin biopsies will be performed in perilesional zone rich in hair follicles. mRNA will be extracted from freshly isolated hair follicle cells and some slides will be prepared and stored at -80°C to perform immunohistochemistry analysis on freshly isolated hair follicle cells. PBMC and serum will be collected.

All these biological samples will allow us to quantify the replicative stress in HS-ORS of each patient, and to quantify several cytokine of interest : IFN de type 1, IL-17, IL-6, TNF-α, IL-10

This study will allow investigators to evaluate the rate of patients with replicative stress in hair follicle stem cells in Hidradenitis Suppurativa. The investigator will also determine whether HF-SC replication stress correlates with clinical characteristics and/or with clinical course and/or comorbidities.

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • cytokine
  • inflammation
  • replicative stress
  • Hidradenitis Suppurativa
03

In context

Hidradenitis Suppurativa

277 studies on the registry are indexed under Hidradenitis Suppurativa; 88 are open to participants now.

This study's planned enrollment of 200 is above the median of 45 across 195 interventional studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients referred to the consultation of dermatology of Henri Mondor Hospital
  • Diagnosis of Hidradenitis Suppurativa
  • Age> 18 y.o.
  • Affiliation to a social security system

Exclusion criteria

Exclusion Criteria:

  • Patient under tutorship or curatorship
  • Breastfeeding or pregnant women
  • Refusal to sign the consent letter
  • Patients benefiting from State Medical Aid
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Physiopathologic exploration

    A non randomised study with one arm, addind experimental acts to standard of care (skin biopsy and biological sample ) in order to explore Hidradenitis Suppurativa physiopathology

    Other: Skin biopsy · Other: Blood sample

Interventions

  • OtherSkin biopsy

    A maximum of 2 superficial skin biopsies (epidermis/dermis), allowing 10 hair follicles to be obtained, at the edge of the affected area, in healthy territory (excluding the face and folds but not excluding the pubic region), at initiation visit.

  • OtherBlood sample

    42mL of blood (6 tubes of 7mL) sampled at initiation visit

06

What researchers measure

Primary outcomes

  1. Replicative stress in hair follicle stem cells in Hidradenitis Suppurativa

    Evaluation of the rate of patients with replicative stress in hair follicle stem cells in Hidradenitis Suppurativa

    Time frame: The primary outcome will be evaluated at baseline

07

Study locations

1 of 1 sites recruiting
  • Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
    Créteil, Val-de-marne 94010, France
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05531747
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Sep 8, 2022
Start date
Jun 13, 2022
Primary completion
Jun 13, 2029 (estimated)
Completion
Dec 13, 2029 (estimated)
Last update
Feb 6, 2025

Study contacts

Claire HOTZ, MD
Contact
claire.hotz@aphp.fr
33-1-49-81-37-96
Philippe Le Corvoisier, MD PhD
Contact
philippe.lecorvoisier@aphp.fr
33-1-49-81-37-96

Oversight

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

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