The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis (VERIMMUNE)
Hidradenitis Suppurativa (HS)
About this trial
This is an interventional diagnostic trial for Hidradenitis Suppurativa (HS)
Eligibility Criteria
Inclusion Criteria: 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 For woman with childbearing potential, negative pregnancy test at the inclusion visit Specific criteria for HS patients 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) Exclusion Criteria: Pregnancy or breast-feeding women Subject treated by allergen immunotherapy within 4 weeks before inclusion Subject treated by Non-Steroidal Anti-Inflammatory Drugs (NSAID), antibiotics or proton-pump inhibitors within 4 weeks before inclusion Subject treated by live (attenuated) vaccine within 4 weeks before inclusion Subject treated by anti-viral treatment within 4 weeks before inclusion Subject treated by anti-diarrhea treatment including, but not limited to Loperamide Subject treated by immunosuppressive/immunomodulatory substances including oral corticosteroid or biological agents within 4 weeks before inclusion 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 in an exclusion period from a previous study or who is participating in another clinical trial using a drug Specific criteria for HS patients 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 treated for their HS by immunosuppressants or intralesional corticosteroids within 4 weeks before the inclusion Subject treated for their HS by topical antibiotics within 4 weeks before the inclusion Subject previously treated with monoclonal antibodies
Sites / Locations
- Department of Dermatology-Hôpital Edouard Herriot
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Hidradenitis Suppurativa (HS) Patients
Healthy Subjects
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)
blood sample (16 mL)