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Recruiting NCT06599411

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

— Observational Atopic Dermatitis Psoriasis Hidradenitis Suppurativa Lichen Planus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sampling, Sampling.
Who it may be relevant to
Registry conditions: Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa, Lichen Planus. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Identification Des Marqueurs Biologiques cutanés et Sanguins prédictifs de réponse Aux Traitements systémiques au Cours Des Maladies cutanées Inflammatoires Chroniques

Overview

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.

Interventions

  • Other Sampling
    Collection of an additional volume of blood, Superficial skin biopsy, Skin swab, Hair follicle, Stool,
  • Other Sampling
    Collection of an additional volume of blood, Preservation of post-operative skin remnants, Skin swab, Hair follicle, Stool

Primary outcome measures

  • Therapeutic response [Time frame: At 1 year]
Secondary outcome measures (12)
  • Expression of markers of blood and skin immunological signaling pathways [Time frame: At inclusion]
  • Expression of markers of blood and skin immunological signaling pathways [Time frame: At 4 months]
  • Expression of markers of blood and skin immunological signaling pathways [Time frame: At 1 year]
  • Expression of markers of blood T cell populations and skin transcriptomics [Time frame: At inclusion]
  • Expression of markers of blood T cell populations and skin transcriptomics [Time frame: At 4 months]
  • Expression of markers of blood T cell populations and skin transcriptomics [Time frame: At 1 year]
  • Therapeutic response [Time frame: At inclusion]
  • Therapeutic response [Time frame: At 4 months]
  • Therapeutic response [Time frame: At 1 year]
  • Therapeutic response [Time frame: At 2 years]
  • Therapeutic response [Time frame: At 3 years]
  • Therapeutic response [Time frame: At 4 years]

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, cutaneaous vasculitis, autoimmune bullous dermatosis
  • 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 inflammatory disease.

Exclusion criteria

  • Under guardianship or curatorship
  • Pregnant or breastfeeding woman
  • Lack of affiliation with a social security system
  • Current systemic treatment with immunosupressant (including corticosteroid therapy) or an immunomodulator or received within the last 3 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hôpital Saint Louis — Paris

Identifiers

NCT: NCT06599411 · APHP240183

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗