Clinical trial NCT06599411: Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases
Official title: Identification Des Marqueurs Biologiques cutanés et Sanguins prédictifs de réponse Aux Traitements systémiques au Cours Des Maladies cutanées Inflammatoires Chroniques
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Atopic Dermatitis
Psoriasis
Hidradenitis Suppurativa
Lichen Planus
Cutaneous Lupus
Dermatomyositis
Cutaneaous Scleroderma
Neutrophilic Dermatosis
Cutaneous Granulomatosis
Active Leprosy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by inflammatory skin disease and controls

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.


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.

Primary outcomes:
measure: Therapeutic response
timeFrame: At 1 year
Secondary outcomes:
measure: Expression of markers of blood and skin immunological signaling pathways
timeFrame: At inclusion
measure: Expression of markers of blood and skin immunological signaling pathways
timeFrame: At 4 months
measure: Expression of markers of blood and skin immunological signaling pathways
timeFrame: At 1 year
measure: Expression of markers of blood T cell populations and skin transcriptomics
timeFrame: At inclusion
measure: Expression of markers of blood T cell populations and skin transcriptomics
timeFrame: At 4 months
measure: Expression of markers of blood T cell populations and skin transcriptomics
timeFrame: At 1 year
measure: Therapeutic response
timeFrame: At inclusion
measure: Therapeutic response
timeFrame: At 4 months
measure: Therapeutic response
timeFrame: At 1 year
measure: Therapeutic response
timeFrame: At 2 years
measure: Therapeutic response
timeFrame: At 3 years
measure: Therapeutic response
timeFrame: At 4 years
measure: Therapeutic response
timeFrame: At 5 years
measure: Therapeutic response
timeFrame: At 6 years
measure: Therapeutic response
timeFrame: At 7 years
measure: Therapeutic response
timeFrame: At 8 years
measure: Therapeutic response
timeFrame: At 9 years
measure: Therapeutic response
timeFrame: At 10 years
measure: Microbiota markers
timeFrame: At inclusion
measure: Microbiota markers
timeFrame: At 1 year
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At inclusion
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 4 months
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 1 year
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 2 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 3 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 4 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 5 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 6 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 7 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 8 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 9 years
measure: Proportion of patients suffering from adverse effects of systemic treatments
timeFrame: At 10 years
Other outcomes:
Locations:
Study officials:
References: