Study of the Immunomodulation in the Hidradenitis Suppurativa and Evaluation of a New Therapeutic Strategy
- Conditions
- Hidradenitis Suppurativa
- Interventions
- Biological: Blood testsProcedure: abdominoplastyProcedure: exeresis
- Registration Number
- NCT05208099
- Lead Sponsor
- Lille Catholic University
- Brief 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.).
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with Hidradenitis suppurativa exeresis - Patients with Hidradenitis suppurativa Blood tests - Controls (coming for abdominoplasty) abdominoplasty -
- Primary Outcome Measures
Name Time Method Activation of lymphocytes 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 Day 0 The prevalence of innate lymphoid cells will be determines by cytometry
Gene expression analysis Day 0 A microarray assay will be performed in order to determine the expression of genes of interest.
Prevalence of different types of immune cell populations Day 0 Prevalence of cell populations will be determined by cytometry
Secretome analysis 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.
- Secondary Outcome Measures
Name Time Method Concentration of exosomes Day 0 The concentration of exosomes will be measured by the Tunable resistive Pulse sensing method
Efficacity of the Photodynamic Therapy (PDT) Day 0 Quantification of antimicrobial peptides Day 0 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
Size of exosomes Day 0 The size of exosomes will be measured by the Tunable resistive Pulse sensing method
Quantification of wound healing Day 0 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.
Trial Locations
- Locations (2)
Hôpital Saint Vincent-de-Paul, Service de Dermatologie-Vénéréologie
🇫🇷Lille, France
Hôpital Saint Philibert - Service de Chirurgie Viscérale
🇫🇷Lomme, France