The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis

NCT05735925 | Unknown

• 1 other identifier: 2022-A02408-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hidradenitis Suppurativa (HS) is a chronic disabling inflammatory skin disorder associated with the development of painful and purulent lesions of the folds (armpits, inguinal folds, sub-mammary glands). HS most often develops in adolescence or young adulthood and is characterized by inflammation of the pilo-sebaceous system, of progressive severity (folliculitis, nodule, abscess, fistula). The pathogenesis of HS is still poorly understood: the fact that patients respond to combinations of antibiotics and/or immunosuppressive treatments suggests that the disease could be due to a dysregulated immune response against microbial skin flora. Unconventional lymphocytes (UL), classically considered being at the interface of innate and adaptive immunity, play an important role in immune protection against microbial flora. But UL dysfunction has also been reported in many autoimmune diseases involving various tissues (joints, digestive tract, skin). The uncontrolled and chronic activation of these UL by skin microbiota could therefore play a role in the pathogenesis of HS.

Conditions

Hidradenitis Suppurativa (HS)

Outcome Measures

Primary Outcomes (3)

• Number of the different leucocytes subsets

  Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Number of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers

  Day 0

• Frequency of the different leucocytes subsets

  Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Frequency of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers

  Day 0

• Functional phenotype of the different leucocytes subsets

  Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the lesional skin versus non lesional skin Functional phenotype of the different leucocytes subsets (unconventional and conventional lymphocytes) in the blood of HS patients versus healthy volunteers

  Day 0

Secondary Outcomes (8)

• Quantitative RNA

  Day 0

• TCR Sequencing

  Day 0

• Bacterial diversity

  Day 0

• Bacterial abundance

  Day 0

• Bacterial diversity

  Day 14

Study Arms (2)

Hidradenitis Suppurativa (HS) Patients

EXPERIMENTAL

* Skin swab sampling for bacteriological analysis * Four skin biopsies: a 6-mm and a 4-mm section skin biopsies on a lesional area (inflammatory nodules) a 6-mm and a 4-mm section skin biopsies on a non lesional area \- blood sample (16 mL)

Diagnostic Test: Skin Swab & Skin Biopsies & Blood Sample

Healthy Subjects

NO INTERVENTION

blood sample (16 mL)

Interventions

Skin Swab & Skin Biopsies & Blood Sample DIAGNOSTIC_TEST

These intervention will be necessary to phenotype the immune cells that are present in the skin and blood of HS patients

Hidradenitis Suppurativa (HS) Patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject able to read, understand and give documented informed consent
• Subject willing and able to comply with the protocol requirements for the duration of the study
• Subject with health insurance coverage according to local regulations
• Subject diagnosed with HS for at least 6 months
• Subject diagnosed with moderate-to-severe HS defined by HS PGA≥3
• Subject presenting an HS with inflammatory phenotype defined by the presence of folliculitis, nodules and/or abcesses
• Subject suffering from at least 4 flares/year and presenting 5 active inflammatory lesions (nodules and/or abcesses)

You may not qualify if:

• Pregnancy or breast-feeding women
• Subject treated by anti-diarrhea treatment including, but not limited to Loperamide
• Subject presenting spondylo-arthritis or Inflammatory Bowel Disease (IBD)
• Subject with a Body Mass Index (BMI)\<18.5 or BMI\>35
• Subject consuming probiotics or using a specific diet (e.g. gluten free, vegetarian, vegan, intermittent fasting)
• Subject with any additional condition that, in the opinion of the investigator, may interfere with the assessment or put the subject at risk
• Linguistic or mentally incapacity to sign the consent form
• Subject protect by the law (adult under guardianship, or hospitalized in a public or private institution for a reason other than study, or incarcerated)
• Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of HS
• History of allergic reaction to local anesthetic product
• History of wound healing disorders (e.g. hypertrophic scars, keloids)
• History of extensive armpit surgery
• Subject with known active infection to Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV)
• Subject treated for their HS by systemic therapy, investigational or commercial, approved or off label)
• Subject previously treated with monoclonal antibodies

Sponsors & Collaborators

• Association pour la Recherche Clinique et Immunologique: lead

Study Sites (1)

Department of Dermatology-Hôpital Edouard Herriot

Lyon, Rhône, 69003, France

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Sophie GILIBERT, PhD

CONTACT

+33 6 65 37 50 08; sophie.gilibert@lyonrechercheclinique.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 21, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)