Hidradenitis SuppurativaIMOHSNCT05208099
Study of the Immunomodulation in the Hidradenitis Suppurativa and Evaluation of a New Therapeutic Strategy
An observational study of Hidradenitis Suppurativa, run by Lille Catholic University at 2 sites in France.
Trial summary
Hidradenitis suppurativa (HS), also known as Verneuil's disease, is a chronic inflammatory dermatosis of the hair follicule located mainly in the skin folds (axillae, inguinal, submammary, etc.). 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?
- Blood tests, exeresis and abdominoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2024to 30 Jun 2026
- Phase
- Observational
- 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
Study population: Subjects with hidradenitis suppurativa and subjects without hidradenitis suppurativa undergoing abdominoplasty
Who may be able to join
- Adult patients (≥18 years)
- Carrier of moderate to severe (Hurley grade ≥2) hidradenitis suppurativa of classical or gluteal phenotype
- Having an indication for surgical treatment (indication for excision)
- Not receiving immunomodulatory treatments (corticotherapy, biotherapy, apremilast, retinoids) or immunosuppressive treatments (methotrexate, ciclosporin) in the 6 months before inclusion, excluding antibiotics
- Agreement to participate
- Affiliated to social security
Show all 25Show fewer
- Adult patients (≥18 years)
- With no history of hidradenitis suppurativa or lesions suggestive of hidradenitis suppurativa (recurrent fold abscesses, recurrent fold suppuration, repeated draining in fold areas)
- With an indication for abdominoplasty surgery
- Not receiving immunomodulatory treatments (corticotherapy, biotherapy, apremilast, retinoids) or immunosuppressive treatments (methotrexate, ciclosporin) in the 6 months preceding inclusion, excluding antibiotics
- Agreement to participate
- Affiliated to social security
- Criteria for non-inclusion of patients with HS :
- Immunosuppression, autoimmune disease(s), cancerous disease, or acute or chronic infectious disease
- Difficulty understanding or reading French
- Patients already included in a therapeutic interventional trial
- Patients under guardianship or curatorship
- Pregnant or breast feeding women
- Syndromic hidradenitis suppurativa, hidradenitis suppurativa of follicular phenotype
- Criteria for non-inclusion of controls receiving abdominoplasty :
- Immunosuppression, autoimmune disease(s), cancerous disease, or acute or chronic infectious disease
- Difficulty understanding or reading french
- Patients already included in a therapeutic interventional trial
- Patients under guardianship or curatorship
- Pregnant or breastfeeding women
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Saint Vincent-de-Paul, Service de Dermatologie-Vénéréologie
Lille, 59020
Marie LAMIAUX
Hôpital Saint Philibert - Service de Chirurgie Viscérale
Lomme, 59462
André DABROWSKI
About this study
Official title: Study of the Immunomodulation of the Immune Response in Hidradenitis Suppurativa and in Vitro and ex Vivo Evaluation of a New Therapeutic Strategy (IMOHS)
Hidradenitis suppurativa (HS), also known as Verneuil's disease, is a chronic inflammatory dermatosis of the hair follicule located mainly in the skin folds (axillae, inguinal, submammary, etc.).
Currently, treatments are mainly limited to the use of broad-spectrum antibiotics in order to control outbreaks of hidradenitis suppurativa. Surgical treatment is the only curative treatment, but requires disfiguring removals with major scarring consequences.
Read more
Pathophysiologically, HS appears to be a primary abnormality of the pilosebaceous-apocrine unit, causing follicular occlusion, followed by the development of perifollicular cysts with commensal bacterial overgrowth, and finally rupture into the dermis causing an exaggerated inflammatory response. At present, few studies have examined the role of the regulatory immune system and its involvement in this disease.
We are also interested in analyzing the impact of new therapeutic strategies on hidradenitis suppurativa, and more particularly the impact of photodynamic therapy (PDT) which is a technique that has been used for a long time in dermatology, notably for the treatment of precancerous and cancerous lesions.
This technique has shown interesting results on inflammatory dermatoses such as acne.
This research consists in studying the immunomodulation of the immune response in HS and in evaluating a new therapeutic strategy based on PDT alone or in combination with antimicrobial peptides (PAMs).
Read the detailed description
Hidradenitis suppurativa (HS), also known as Verneuil's disease, is a chronic inflammatory dermatosis of the hair follicule located mainly in the skin folds (axillae, inguinal, submammary, etc.). The disease is characterized by pain, inflammatory nodules, abscesses, fistulas and hypertrophic " rope " scars that considerably alter the quality of life of patients.
Currently, the treatment is mainly limited to the use of broad-spectrum antibiotics in order to control the outbreaks of HS. This medical treatment is currently controversial because of the risk of inducing bacterial resistance. Surgical treatment is the only curative treatment, but requires disfiguring removals with major scarring consequences.
Pathophysiologically, HS appears to be a primary abnormality of the pilosebaceous-apocrine unit, which causes follicular occlusion, followed by the development of perifollicular cysts with commensal bacterial proliferation, and finally rupture into the dermis causing an exaggerated inflammatory response. At present, few studies have examined the role of the regulatory immune system and its involvement in this disease.
In the context of HS, it has recently been shown from patient samples that there is an abnormality concerning the stem cells present in the follicular bulb. It can be asked whether the abnormalities observed in hair follicle stem cells of HS patients could be the source of pro-inflammatory exosomes playing a role in HS flares.
The impact of new therapeutic strategies on hidradenitis suppurativa, and more particularly the impact of photodynamic therapy (PDT) which is a technique used for a long time in dermatology, notably for the treatment of precancerous and cancerous lesions will be also evaluated.
This technique has shown interesting results on inflammatory dermatoses such as acne with an " antibiotic " effect.
Thus, this research consists in studying the immunomodulation of the immune response in HS and in evaluating a new therapeutic strategy based on PDT alone or in combination with antimicrobial peptides (PAMs). This is a prospective observational multicenter study of type 3. This study is composed of two steps : first an in vitro part, secondly an ex vivo part allowing to validate the results obtained in vitro on human samples.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Blood tests, exeresis, abdominoplasty
- Keywords
- Hidradenitis suppurativa, inflammatory nodules, abscesses, fistulas, scars, surgery
- Medical subject headings
- Hidradenitis Suppurativa, Abscess, Fistula, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsBiological
For patients, it will be performed:
- a collection of blood samples (3 tubes of 5 mL) according to the usual medical management, in order to search for cardiovascular comorbidities associated with HS,
- A collection of 3 EDTA tubes and 2 additional dry tubes of 5 mL each according to the needs of the study.
exeresisProcedure or surgery
For patients, it will be performed:
- 6 tissue samples from the total excision specimen: two samples from the acute inflammatory zone (nodule, abscess, fistula) of 1 cm3; two samples from the chronic lesion zone (scar) of 1 cm3 and two samples from the peri-lesion zone (in the margin) of 1 cm3 on fresh tissue.
abdominoplastyProcedure or surgery
For the controls, 6 fresh skin samples of 1 cm3 each will be taken from the abdominoplasty operation:
- four in the center,
- two in the margin
| Study group | Role | What they receive |
|---|---|---|
| Patients with Hidradenitis suppurativa | Not described Receives: Biological: Blood tests; Procedure: exeresis | |
| Controls (coming for abdominoplasty) | Not described Receives: Procedure: abdominoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different types of immune cell populations
Prevalence of cell populations will be determined by cytometry
Measured: Day 0
Activation of lymphocytes
The activation state of circulating lymphocytes will be analyzed by flow cytometry using antibodies coupled to fluorochromes specifically targeting the following membrane markers: CD4, CD30, CD69, Anti-HLADR, CD152, CD197, CD25, CD8.
Measured: Day 0
Prevalence of innate lymphoid cells
The prevalence of innate lymphoid cells will be determines by cytometry
Measured: Day 0
Gene expression analysis
A microarray assay will be performed in order to determine the expression of genes of interest.
Measured: Day 0
Secretome analysis
The pg/mL concentrations of different cytokines in the serum of HS patients versus healthy controls will be determined using ELISA (Luminex™) in order to be able to determine the differences in activation of immune pathways : Th1/Th2, Th9/Th17/Th22/Treg, inflammatory cytokines, Immunosuppressive cytokine.
Measured: Day 0
Secondary outcomes (5)
Size of exosomes
The size of exosomes will be measured by the Tunable resistive Pulse sensing method
Measured: Day 0
Concentration of exosomes
The concentration of exosomes will be measured by the Tunable resistive Pulse sensing method
Measured: Day 0
Quantification of antimicrobial peptides
Several antimicrobial peptides such as elafin/SHALP, dermcidin, S100A7/psoriasin, S100A8/calgranulin A, S100A9/calgranulin B, LL-37 (cathelicidin), h-βd1, h-βd2, h-βd3, h-βd4, ribonuclease 7, SLPI/ALP from HS patient serum versus blood baqs (control) as well as in supernatants of HS lesion tissue versus abdominoplasty tissue (control) cultured in microslices will be quantified by ELISA
Measured: Day 0
Quantification of wound healing
Wound healing capacity
We will evaluate the ability to restore wound healing in in vitro HS models (HaCaT NCSTN-/-line) versus the healthy model (HaCaT wild type) by performing wound healing and migration assays (IBIDI) with and without the addition of exogenous PAMs lacking in HS.
Measured: Day 0
Efficacity of the Photodynamic Therapy (PDT)
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 posted26 Jan 2022
- Study start1 Jan 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie LAMIAUX, Principal investigator, Lille Catholic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208099
- Sponsor's protocol ID
- RC-P00111
- Acronym
- IMOHS
- Status last verified
- Oct 2023
- First submitted
- 12 Jan 2022
- Last updated
- 31 Oct 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immunomodulation of the Immune Response in Hidradenitis Suppurativa and in Vitro and ex Vivo Evaluation of a New Therapeutic Strategy (IMOHS)
- ClinicalTrials.gov ID
- NCT05208099
- Acronym / sponsor ID
- IMOHS / RC-P00111
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis suppurativa, inflammatory nodules, abscesses, fistulas, scars, surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Jan 2022 (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), also known as Verneuil's disease, is a chronic inflammatory dermatosis of the hair follicule located mainly in the skin folds (axillae, inguinal, submammary, etc.).
Currently, treatments are mainly limited to the use of broad-spectrum antibiotics in order to control outbreaks of hidradenitis suppurativa. Surgical treatment is the only curative treatment, but requires disfiguring removals with major scarring consequences.
Pathophysiologically, HS appears to be a primary abnormality of the pilosebaceous-apocrine unit, causing follicular occlusion, followed by the development of perifollicular cysts with commensal bacterial overgrowth, and finally rupture into the dermis causing an exaggerated inflammatory response. At present, few studies have examined the role of the regulatory immune system and its involvement in this disease.
We are also interested in analyzing the impact of new therapeutic strategies on hidradenitis suppurativa, and more particularly the impact of photodynamic therapy (PDT) which is a technique that has been used for a long time in dermatology, notably for the treatment of precancerous and cancerous lesions.
This technique has shown interesting results on inflammatory dermatoses such as acne.
This research consists in studying the immunomodulation of the immune response in HS and in evaluating a new therapeutic strategy based on PDT alone or in combination with antimicrobial peptides (PAMs).
Detailed description
Hidradenitis suppurativa (HS), also known as Verneuil's disease, is a chronic inflammatory dermatosis of the hair follicule located mainly in the skin folds (axillae, inguinal, submammary, etc.). The disease is characterized by pain, inflammatory nodules, abscesses, fistulas and hypertrophic " rope " scars that considerably alter the quality of life of patients.
Currently, the treatment is mainly limited to the use of broad-spectrum antibiotics in order to control the outbreaks of HS. This medical treatment is currently controversial because of the risk of inducing bacterial resistance. Surgical treatment is the only curative treatment, but requires disfiguring removals with major scarring consequences.
Pathophysiologically, HS appears to be a primary abnormality of the pilosebaceous-apocrine unit, which causes follicular occlusion, followed by the development of perifollicular cysts with commensal bacterial proliferation, and finally rupture into the dermis causing an exaggerated inflammatory response. At present, few studies have examined the role of the regulatory immune system and its involvement in this disease.
In the context of HS, it has recently been shown from patient samples that there is an abnormality concerning the stem cells present in the follicular bulb. It can be asked whether the abnormalities observed in hair follicle stem cells of HS patients could be the source of pro-inflammatory exosomes playing a role in HS flares.
The impact of new therapeutic strategies on hidradenitis suppurativa, and more particularly the impact of photodynamic therapy (PDT) which is a technique used for a long time in dermatology, notably for the treatment of precancerous and cancerous lesions will be also evaluated.
This technique has shown interesting results on inflammatory dermatoses such as acne with an " antibiotic " effect.
Thus, this research consists in studying the immunomodulation of the immune response in HS and in evaluating a new therapeutic strategy based on PDT alone or in combination with antimicrobial peptides (PAMs). This is a prospective observational multicenter study of type 3. This study is composed of two steps : first an in vitro part, secondly an ex vivo part allowing to validate the results obtained in vitro on human samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Hidradenitis suppurativa | – | Biological: Blood tests, Procedure: exeresis |
| Controls (coming for abdominoplasty) | – | Procedure: abdominoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with hidradenitis suppurativa and subjects without hidradenitis suppurativa undergoing abdominoplasty
Key inclusion criteria (25 listed)
- Adult patients (≥18 years)
- Carrier of moderate to severe (Hurley grade ≥2) hidradenitis suppurativa of classical or gluteal phenotype
- Having an indication for surgical treatment (indication for excision)
- Not receiving immunomodulatory treatments (corticotherapy, biotherapy, apremilast, retinoids) or immunosuppressive treatments (methotrexate, ciclosporin) in the 6 months before inclusion, excluding antibiotics
- Agreement to participate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Blood testsFor patients, it will be performed: * a collection of blood samples (3 tubes of 5 mL) according to the usual medical management, in order to search for cardiovascular comorbidities associated with HS, * A collection of 3 EDTA tubes and 2 additional dry tubes of 5 mL each according to the needs of the study. | Biological | Patients with Hidradenitis suppurativa |
| exeresisFor patients, it will be performed: - 6 tissue samples from the total excision specimen: two samples from the acute inflammatory zone (nodule, abscess, fistula) of 1 cm3; two samples from the chronic lesion zone (scar) of 1 cm3 and two samples from the peri-lesion zone (in the margin) of 1 cm3 on fresh tissue. | Procedure or surgery | Patients with Hidradenitis suppurativa |
| abdominoplastyFor the controls, 6 fresh skin samples of 1 cm3 each will be taken from the abdominoplasty operation: * four in the center, * two in the margin | Procedure or surgery | Controls (coming for abdominoplasty) |
Primary outcome
Prevalence of different types of immune cell populations
Time frame: Day 0
Prevalence of cell populations will be determined by cytometry
Activation of lymphocytes
Time frame: Day 0
The activation state of circulating lymphocytes will be analyzed by flow cytometry using antibodies coupled to fluorochromes specifically targeting the following membrane markers: CD4, CD30, CD69, Anti-HLADR, CD152, CD197, CD25, CD8.
Prevalence of innate lymphoid cells
Time frame: Day 0
The prevalence of innate lymphoid cells will be determines by cytometry
Gene expression analysis
Time frame: Day 0
A microarray assay will be performed in order to determine the expression of genes of interest.
Secretome analysis
Time frame: Day 0
The pg/mL concentrations of different cytokines in the serum of HS patients versus healthy controls will be determined using ELISA (Luminex™) in order to be able to determine the differences in activation of immune pathways : Th1/Th2, Th9/Th17/Th22/Treg, inflammatory cytokines, Immunosuppressive cytokine.
5 secondary outcomes
Size of exosomes
Time frame: Day 0
Concentration of exosomes
Time frame: Day 0
Quantification of antimicrobial peptides
Time frame: Day 0
Quantification of wound healing
Time frame: Day 0
Efficacity of the Photodynamic Therapy (PDT)
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 31 Oct 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.
Marie LAMIAUX principal investigator
Lille Catholic University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa, run by Lille Catholic University at 2 sites 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 25 inclusion and 0 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 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Amélie LANSIAUX, Md, PhD (+33320225269, lansiaux.amelie@ghicl.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different types of immune cell populations (time frame: Day 0). The study lists 5 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 31 Oct 2023.