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

NCT ID: NCT06599411

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2044-10-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Affected by inflammatory skin disease

Sampling

Intervention Type: OTHER

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

Controls

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

Sampling

Intervention Type: OTHER

Collection of an additional volume of blood Preservation of post-operative skin remnants Skin swab

Interventions

Sampling

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

Intervention Type: OTHER

Sampling

Collection of an additional volume of blood Preservation of post-operative skin remnants Skin swab

Intervention Type: OTHER

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Charles Cassius, MD

Role: CONTACT

charles.cassius@aphp.fr

630944832 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

142499742 ext. +33

Other Identifiers

APHP240183

Identifier Type: -

Identifier Source: org_study_id