Study of the Immunomodulation in the Hidradenitis Suppurativa and Evaluation of a New Therapeutic Strategy

NCT05208099 | Not Yet Recruiting

• 1 other identifier: RC-P00111
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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).

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis suppurativa; inflammatory nodules; abscesses; fistulas; scars; surgery

Outcome Measures

Primary Outcomes (5)

• Prevalence of different types of immune cell populations

  Prevalence of cell populations will be determined by cytometry

  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.

  Day 0

• Prevalence of innate lymphoid cells

  The prevalence of innate lymphoid cells will be determines by cytometry

  Day 0

• Gene expression analysis

  A microarray assay will be performed in order to determine the expression of genes of interest.

  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.

  Day 0

Secondary Outcomes (5)

• Size of exosomes

  Day 0

• Concentration of exosomes

  Day 0

• Quantification of antimicrobial peptides

  Day 0

• Quantification of wound healing

  Day 0

• Efficacity of the Photodynamic Therapy (PDT)

  Day 0

Study Arms (2)

Patients with Hidradenitis suppurativa

Biological: Blood tests; Procedure: exeresis

Controls (coming for abdominoplasty)

Procedure: abdominoplasty

Interventions

Blood tests BIOLOGICAL

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.

Patients with Hidradenitis suppurativa

exeresis PROCEDURE

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.

Patients with Hidradenitis suppurativa

abdominoplasty PROCEDURE

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

Controls (coming for abdominoplasty)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with hidradenitis suppurativa and subjects without hidradenitis suppurativa undergoing abdominoplasty

You may qualify if:

• 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)
• Agreement to participate
• Affiliated to social security
• 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
• Agreement to participate
• Affiliated to social security
• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (2)

Hôpital Saint Vincent-de-Paul, Service de Dermatologie-Vénéréologie

Lille, 59020, France

Location

Hôpital Saint Philibert - Service de Chirurgie Viscérale

Lomme, 59462, France

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Abscess; Fistula; Cicatrix

Interventions

Hematologic Tests; Abdominoplasty

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Fibrosis

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cosmetic Techniques; Therapeutics; Plastic Surgery Procedures; Surgical Procedures, Operative

Study Officials

• Marie LAMIAUX

  Lille Catholic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie LANSIAUX, Md, PhD

CONTACT

+33320225269; lansiaux.amelie@ghicl.net

Anne-Sophie BLAIN, CRA

CONTACT

+33320225732; blain.anne-sophie@ghicl.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 26, 2022
• Study Start: January 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)