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

Not yet recruiting

• Conditions: Atopic Dermatitis; Psoriasis; Hidradenitis Suppurativa; Lichen Planus; Cutaneous Lupus; Dermatomyositis; Cutaneaous Scleroderma; Neutrophilic Dermatosis; Cutaneous Granulomatosis; Active Leprosy
• Interventions: Other: Sampling

• Registration Number: NCT06599411
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-13
• Study First Submitted QC: 2024-09-16
• Last Update Submitted: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Study Start: 2024-10-01
• Primary Completion: 2035-10-01
• Study Completion: 2044-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Sampling	Affected by inflammatory skin disease
Controls	Sampling	Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants

Primary Outcome Measures

Name	Time	Method
Therapeutic response	At 1 year	It is defined as complete or partial remission on the Investigator/Physician Global Assessment (IGA/PGA) scale.

Secondary Outcome Measures

Name	Time	Method
Expression of markers of blood and skin immunological signaling pathways	At 1 year	Mainly Th1, Th2, Th9, Th17, Th22 and Treg
Expression of markers of blood T cell populations and skin transcriptomics	At 1 year
Therapeutic response	At 10 years	Based on markers of blood T cell populations and skin transcriptomics
Microbiota markers	At 1 year	Identification of cluster specific to the pathology, identification of an over-representation of one or more microbiological species.; For patients only
Proportion of patients suffering from adverse effects of systemic treatments	At 10 years	According to the CTCAE classification and MedDRA