Hidradenitis Suppurativa (HS)VERIMMUNENCT05735925
The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis
A study testing Skin Swab & Skin Biopsies & Blood Sample in people with Hidradenitis Suppurativa (HS), run by Association pour la Recherche Clinique et Immunologique at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Skin Swab & Skin Biopsies & Blood Sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2023to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Department of Dermatology-Hôpital Edouard Herriot
Lyon, Rhône, 69003
Axel VILLANI, M.D Ph.D, 04 72 11 72 11, axel.villani@chu-lyon.fr
About this study
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.
Read the detailed description
The aim of this exploratory study is to analyze the interplay between microbiota and the innate and adaptative immune response in the pathogenesis of HS. To better understand this host-microbiota interplay, we will assess the number, frequency and functional phenotypes of the different lymphocyte subsets in HS patients, with a special focus regarding the UL. In the same time, we will assess the diversity and nature of skin microbiota of the same patients. Finally, we will explore the relation between the immune response and the skin microbiota in HS, using correlation analysis (Spearman coefficient).
In this study, HS patients will be their own control for leucocyte phenotyping, cytokine analysis and T Cells Receptor (TCR) sequencing (skin biopsies) and for skin microbiota analysis. Paired (age/sex) healthy volunteers will be controls for gut microbiota analysis and for immunophenotyping of circulating leukocytes (Peripheral Blood Mononuclear Cells (PBMC) analysis).
- Conditions
- Hidradenitis Suppurativa (HS)
- Being tested
- Skin Swab & Skin Biopsies & Blood Sample
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Swab & Skin Biopsies & Blood SampleDiagnostic test
These intervention will be necessary to phenotype the immune cells that are present in the skin and blood of HS patients
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Skin Swab & Skin Biopsies & Blood Sample |
| Healthy Subjects | No intervention | blood sample (16 mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 0
Secondary outcomes (8)
Quantitative RNA
Quantitative RNA expression of selected cytokines' genes in the lesional skin versus non lesional skin
Measured: Day 0
TCR Sequencing
TCR sequencing in the lesional skin versus non-lesional skin
- TCR sequencing in the blood of HS patients versus healthy volunteers
- Correlation between lesional skin and blood clones in the same patient will be searched
Measured: Day 0
Bacterial diversity
Bacterial diversity of microbes from skin flora in lesional skin versus non lesional skin
Measured: Day 0
Bacterial abundance
Bacterial abundance of microbes from skin flora in lesional skin versus non lesional skin
Measured: Day 0
Bacterial diversity
Bacterial diversity of microbes from gut flora in HS patients versus healthy volunteers
Measured: Day 14
Bacterial abundance
Bacterial abundance of microbes from gut flora in HS patients versus healthy volunteers
Measured: Day 14
Presence of bacterial DNA translocation
Presence of bacterial DNA translocation in the blood of HS patients
Measured: Day 0
Description of bacterial DNA translocation
Genus, phyla, species, specific bacteria abundance and overall diversity in the blood of HS patients
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study startFeb 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour la Recherche Clinique et Immunologique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735925
- Sponsor's protocol ID
- 2022-A02408-35
- Acronym
- VERIMMUNE
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Host-microbiota Interplay in Hidradenitis Suppurativa Pathogenesis
- ClinicalTrials.gov ID
- NCT05735925
- Acronym / sponsor ID
- VERIMMUNE / 2022-A02408-35
- Conditions
- Hidradenitis Suppurativa (HS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Association pour la Recherche Clinique et ImmunologiqueUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The aim of this exploratory study is to analyze the interplay between microbiota and the innate and adaptative immune response in the pathogenesis of HS. To better understand this host-microbiota interplay, we will assess the number, frequency and functional phenotypes of the different lymphocyte subsets in HS patients, with a special focus regarding the UL. In the same time, we will assess the diversity and nature of skin microbiota of the same patients. Finally, we will explore the relation between the immune response and the skin microbiota in HS, using correlation analysis (Spearman coefficient).
In this study, HS patients will be their own control for leucocyte phenotyping, cytokine analysis and T Cells Receptor (TCR) sequencing (skin biopsies) and for skin microbiota analysis. Paired (age/sex) healthy volunteers will be controls for gut microbiota analysis and for immunophenotyping of circulating leukocytes (Peripheral Blood Mononuclear Cells (PBMC) analysis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hidradenitis Suppurativa (HS) Patients | Experimental | Diagnostic Test: Skin Swab & Skin Biopsies & Blood Sample* 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) |
| Healthy Subjects | No intervention | –blood sample (16 mL) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Swab & Skin Biopsies & Blood SampleThese intervention will be necessary to phenotype the immune cells that are present in the skin and blood of HS patients | Diagnostic test | Hidradenitis Suppurativa (HS) Patients |
Primary outcome
Number of the different leucocytes subsets
Time frame: Day 0
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
Frequency of the different leucocytes subsets
Time frame: Day 0
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
Functional phenotype of the different leucocytes subsets
Time frame: Day 0
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
8 secondary outcomes
Quantitative RNA
Time frame: Day 0
TCR Sequencing
Time frame: Day 0
Bacterial diversity
Time frame: Day 0
Bacterial abundance
Time frame: Day 0
Bacterial diversity
Time frame: Day 14
Bacterial abundance
Time frame: Day 14
Presence of bacterial DNA translocation
Time frame: Day 0
Description of bacterial DNA translocation
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin Swab & Skin Biopsies & Blood Sample in people with Hidradenitis Suppurativa (HS), run by Association pour la Recherche Clinique et Immunologique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie GILIBERT, PhD (+33 6 65 37 50 08, sophie.gilibert@lyonrechercheclinique.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of the different leucocytes subsets (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.