Hidradenitis SuppurativaNCT02833909
Activation of a Cutaneous Inflammasome in the Skin of Hidradenitis Suppurativa Patients
A study testing surgery in people with Hidradenitis Suppurativa, run by CHU de Reims at 1 site in France.
Trial summary
The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of patients treated surgically for this disease. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Mar 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with moderate to severe HS in the Dermatology department of Reims CHU, and eligible for surgery
- Patients accepting to participate to the study (signed consent)
- Patients affiliated to a certain social scheme
- Controls with plastic surgery but without HS, affiliated to a certain social scheme and accepting to participate
Who cannot join
- Patients <18yo
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ex Vivo Study of the Inflammatory Response Associated With Hidradenitis Suppurativa
The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of patients treated surgically for this disease.
The investigators hypothesize that Th17-derived cytokines, especially Interleukin (IL) IL-17, could serve as a relay in the inflammatory process leading to HS severity and recurrences.
Read the detailed description
The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of patients treated surgically for this disease.
The investigators hypothesize that Th17-derived cytokines, especially IL-17, could serve as a relay in the inflammatory process leading to HS severity and recurrences.To fulfil this proposal, the investigators will aim at demonstrating and characterizing the presence of an inflammasome associated to HS disease - Hypothesis It is widely accepted that hyperkeratinisation and follicular occlusion originate infection thereof causing skin inflammation. The investigators here hypothesized that host-derived danger signals led to the release of inflammatory mediators such as IL-1β by activating an inflammasome structure.
The inflammasome is a molecular platform controlling the expression and the activation of IL-1β via different sensors. The proinflammatory cytokine IL-1β could subsequently lead to the recruitment and orientation of lymphocytes towards a Th17 subtype creating a feedback loop maintaining excessive tissue inflammation in HS.
If such a complex inflammatory process is present in HS, blocking both the bacterial-induced (IL-1 β) and the sterile-associated (IL-17) inflammation would largely improve the therapeutic benefit for HS patients.
- Experimental approach
The investigators will seek to highlight the presence of inflammasome sensors and effectors in skin explants from HS compared to control skin. For this original physiopathological study, 10 lesional skins excised from HS patients or controls (plastic surgery) after they signed informed consent as required by the ethical review board (CPP accepted on the 23-01-2015) will be investigated. HS disease severity will be based on staging according to Hurley staging. Six mm skin punches will be harvested from control explants and from both in situ and peri-lesional sites of HS skin explants. Skin samples will be handled either straight forwardly (day 0) or after a period of tissue culture of 4 days with or w/out treatments.
All experiments will be conducted as follows:
- Ex vivo skin tissue samples will be inserted in a Transwell® filter and cultured over a period of 4 days with or w/out antibiotics (Rifampicin, Clindamycin).
- Both at day 0 and day 4:
- one set of skin samples will be embedded to analyze the presence of inflammasome sensors and effectors by immunohistochemistry (IHC)
- Another set will be homogenized for cytokines determination (ELISA) and cell stimulation (see below)
- Homogenized samples will be treated or not with anti-cytokine antibodies (Secukinumab vs isotype) for 4 hours before addition to keratinocytes cell line or monocyte/macrophage cell line. The influence of IL-17 and bacterial infection on inflammasome activation in these cell lines will be investigated as above described and associated with PCR technique.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- surgery
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryOther
| Study group | Role | What they receive |
|---|---|---|
| HS | Experimental | Not described Receives: Other: surgery |
| Controls | Experimental | Not described Receives: Other: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytokine quantification (IL1-β) by ELISA
Measured: up to 4 days
cytokine quantification (IL-10) by ELISA
Measured: up to 4 days
cytokines quantification (IL-13) by ELISA
Measured: up to 4 days
cytokines quantification (IL-18) by ELISA
Measured: up to 4 days
cytokines quantification (CXCL10) by ELISA
Measured: up to 4 days
cytokines quantification (TNFα) by ELISA
Measured: up to 4 days
cytokines quantification (TGFβ) by ELISA
Measured: up to 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833909
- Sponsor's protocol ID
- PO14129
- Status last verified
- Jul 2016
- First submitted
- 4 Jul 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
Sanchez J, Le Jan S, Muller C, Francois C, Renard Y, Durlach A, Bernard P, Reguiai Z, Antonicelli F. Matrix remodelling and MMP expression/activation are associated with hidradenitis suppurativa skin inflammation. Exp Dermatol. 2019 May;28(5):593-600. doi: 10.1111/exd.13919.
PubMed 30903721
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ex Vivo Study of the Inflammatory Response Associated With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT02833909
- Acronym / sponsor ID
- PO14129
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 14 Jul 2016 (estimated)
- 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.
The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa (HS) (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of patients treated surgically for this disease.
The investigators hypothesize that Th17-derived cytokines, especially Interleukin (IL) IL-17, could serve as a relay in the inflammatory process leading to HS severity and recurrences.
Detailed description
The objective is to investigate ex vivo the inflammatory response in hidradenitis suppurativa (activation of an inflammasome, role of pro-inflammatory cytokines) in the skin of patients treated surgically for this disease.
The investigators hypothesize that Th17-derived cytokines, especially IL-17, could serve as a relay in the inflammatory process leading to HS severity and recurrences.To fulfil this proposal, the investigators will aim at demonstrating and characterizing the presence of an inflammasome associated to HS disease - Hypothesis It is widely accepted that hyperkeratinisation and follicular occlusion originate infection thereof causing skin inflammation. The investigators here hypothesized that host-derived danger signals led to the release of inflammatory mediators such as IL-1β by activating an inflammasome structure.
The inflammasome is a molecular platform controlling the expression and the activation of IL-1β via different sensors. The proinflammatory cytokine IL-1β could subsequently lead to the recruitment and orientation of lymphocytes towards a Th17 subtype creating a feedback loop maintaining excessive tissue inflammation in HS.
If such a complex inflammatory process is present in HS, blocking both the bacterial-induced (IL-1 β) and the sterile-associated (IL-17) inflammation would largely improve the therapeutic benefit for HS patients.
- Experimental approach
The investigators will seek to highlight the presence of inflammasome sensors and effectors in skin explants from HS compared to control skin. For this original physiopathological study, 10 lesional skins excised from HS patients or controls (plastic surgery) after they signed informed consent as required by the ethical review board (CPP accepted on the 23-01-2015) will be investigated. HS disease severity will be based on staging according to Hurley staging. Six mm skin punches will be harvested from control explants and from both in situ and peri-lesional sites of HS skin explants. Skin samples will be handled either straight forwardly (day 0) or after a period of tissue culture of 4 days with or w/out treatments.
All experiments will be conducted as follows:
- Ex vivo skin tissue samples will be inserted in a Transwell® filter and cultured over a period of 4 days with or w/out antibiotics (Rifampicin, Clindamycin).
- Both at day 0 and day 4:
- one set of skin samples will be embedded to analyze the presence of inflammasome sensors and effectors by immunohistochemistry (IHC)
- Another set will be homogenized for cytokines determination (ELISA) and cell stimulation (see below)
- Homogenized samples will be treated or not with anti-cytokine antibodies (Secukinumab vs isotype) for 4 hours before addition to keratinocytes cell line or monocyte/macrophage cell line. The influence of IL-17 and bacterial infection on inflammasome activation in these cell lines will be investigated as above described and associated with PCR technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS | Experimental | Other: surgery |
| Controls | Experimental | Other: surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with moderate to severe HS in the Dermatology department of Reims CHU, and eligible for surgery
- Patients accepting to participate to the study (signed consent)
- Patients affiliated to a certain social scheme
- Controls with plastic surgery but without HS, affiliated to a certain social scheme and accepting to participate
Key exclusion criteria (1 listed)
- Patients <18yo
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 |
|---|---|---|
| surgery | Other | Controls, HS |
Primary outcome
cytokine quantification (IL1-β) by ELISA
Time frame: up to 4 days
cytokine quantification (IL-10) by ELISA
Time frame: up to 4 days
cytokines quantification (IL-13) by ELISA
Time frame: up to 4 days
cytokines quantification (IL-18) by ELISA
Time frame: up to 4 days
cytokines quantification (CXCL10) by ELISA
Time frame: up to 4 days
cytokines quantification (TNFα) by ELISA
Time frame: up to 4 days
cytokines quantification (TGFβ) by ELISA
Time frame: up to 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 30903721Sanchez J, Le Jan S, Muller C, Francois C, Renard Y, Durlach A, Bernard P, Reguiai Z, Antonicelli F. Matrix remodelling and MMP expression/activation are associated with hidradenitis suppurativa skin inflammation. Exp Dermatol. 2019 May;28(5):593-600. doi: 10.1111/exd.13919.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in people with Hidradenitis Suppurativa, run by CHU de Reims 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytokine quantification (IL1-β) by ELISA (time frame: up to 4 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02833909, which also lists 1 linked publication.
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 Jan 2026.