Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases

NCT06599411 | Not Yet Recruiting

• 1 other identifier: APHP240183
• Study Type: observational
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases. The main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases. The secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.

Conditions

Atopic Dermatitis; Psoriasis; Hidradenitis Suppurativa; Lichen Planus; Cutaneous Lupus; Dermatomyositis; Cutaneaous Scleroderma; Neutrophilic Dermatosis; Cutaneous Granulomatosis; Active Leprosy

Outcome Measures

Primary Outcomes (1)

• Therapeutic response

  It is defined as complete or partial remission on the Investigator/Physician Global Assessment (IGA/PGA) scale.

  At 1 year

Secondary Outcomes (32)

• Expression of markers of blood and skin immunological signaling pathways

  At inclusion

• Expression of markers of blood and skin immunological signaling pathways

  At 4 months

• Expression of markers of blood and skin immunological signaling pathways

  At 1 year

• Expression of markers of blood T cell populations and skin transcriptomics

  At inclusion

• Expression of markers of blood T cell populations and skin transcriptomics

  At 4 months

Study Arms (2)

Patients

Affected by inflammatory skin disease

Other: Sampling

Controls

Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants

Other: Sampling

Interventions

Sampling OTHER

Collection of an additional volume of blood Superficial skin biopsy Skin swab

Patients

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

Patients affected by inflammatory skin disease and controls

You may qualify if:

• Patients:
• Age\>18 years
• Informed consent signed by the patient
• Diagnosis of moderate to severe chronic inflammatory skin disease (IGA score 3 or 4) including: atopic dermatitis, psoriasis, hidradenitis suppurativa, lichen planus, cutaneous lupus, dermatomyositis, cutaneous scleroderma (=morphea), neutrophilic dermatosis, cutaneous granulomatosis
• Or diagnosis of active leprosy (tuberculoid, lepromatous, reversion type 1, reversion type 2, hypersensitivity type 3), excluding pure neurological leprosy. Classification into 5 stages according to the Ridley and Jopling classification \[1\], Reversion reaction (type 1 reaction) and leprous erythema nodosum (type 2 reaction).
• Healthy controls :
• Age\>18 years
• Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants
• Informed consent signed by the patient
• Absence of known cutaneous or systemic inflammatory disease.

You may not qualify if:

• Under guardianship or curatorship
• Pregnant or breastfeeding woman
• Lack of affiliation with a social security system
• Systemic treatment in progress or received less than 3 months ago.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Dermatitis, Atopic; Psoriasis; Hidradenitis Suppurativa; Lichen Planus; Dermatomyositis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Hidradenitis; Sweat Gland Diseases; Lichenoid Eruptions; Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases

Central Study Contacts

Charles Cassius, MD

CONTACT

630944832; charles.cassius@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

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

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2035
• Study Completion (Estimated): October 1, 2044
• Last Updated: September 19, 2024

Record last verified: 2024-08