Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa (Fol-Hydra)
Primary Purpose
Hidradenitis Suppurativa
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Skin biopsy
Blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Hidradenitis Suppurativa focused on measuring cytokine, inflammation, replicative stress, Hidradenitis Suppurativa
Eligibility Criteria
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:
- Patient under tutorship or curatorship
- Breastfeeding or pregnant women
- Refusal to sign the consent letter
- Patients benefiting from State Medical Aid
Sites / Locations
- Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Physiopathologic exploration
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05531747
First Posted
June 14, 2022
Last Updated
September 7, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT05531747
Brief Title
Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa
Acronym
Fol-Hydra
Official Title
Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa
Keywords
cytokine, inflammation, replicative stress, Hidradenitis Suppurativa
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Biological assays will be performed by technician blinded from patients clinical status
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Physiopathologic exploration
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Skin biopsy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sample
Intervention Description
42mL of blood (6 tubes of 7mL) sampled at initiation visit
Primary Outcome Measure Information:
Title
Replicative stress in hair follicle stem cells in Hidradenitis Suppurativa
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Patient under tutorship or curatorship
Breastfeeding or pregnant women
Refusal to sign the consent letter
Patients benefiting from State Medical Aid
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire HOTZ, MD
Phone
33-1-49-81-37-96
Email
claire.hotz@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe Le Corvoisier, MD PhD
Phone
33-1-49-81-37-96
Email
philippe.lecorvoisier@aphp.fr
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Paris - CHU Henri Mondor
City
Créteil
State/Province
Val-de-marne
ZIP/Postal Code
94010
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire HOTZ, MD-PhD
Phone
33-1-49-81-45-11
Email
claire.hotz@aphp.fr
First Name & Middle Initial & Last Name & Degree
Philippe Le Corvoisier, MD-pHD
Phone
33-1-49-81-37-96
Email
philippe.lecorvoisier@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Learn more about this trial
Replicative Stress in Hair Follicle Stem Cells and Pathogeny of Hidradenitis Suppurativa
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