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

ConditionsAtopic DermatitisPsoriasisHidradenitis SuppurativaLichen PlanusCutaneous LupusDermatomyositisCutaneaous SclerodermaNeutrophilic DermatosisCutaneous GranulomatosisActive LeprosyAutoimmune Bullous DermatosisCutaneous Vasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial population

Patients affected by inflammatory skin disease and controls

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sampling

    Other intervention

    Collection of an additional volume of blood, Superficial skin biopsy, Skin swab, Hair follicle, Stool,

  • Sampling

    Other intervention

    Collection of an additional volume of blood, Preservation of post-operative skin remnants, Skin swab, Hair follicle, Stool

Treatment groups

830 Participants
are divided into 2 treatment groups
Group A: Patients1 intervention
Group B: Controls1 intervention

Trial outcomes

Primary outcomes

1

Therapeutic response

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

Time frame
At 1 year

Secondary outcomes

1

Expression of markers of blood and skin immunological signaling pathways

Mainly Th1, Th2, Th9, Th17, Th22 and Treg

Time frame
At inclusion
2

Expression of markers of blood and skin immunological signaling pathways

Mainly Th1, Th2, Th9, Th17, Th22 and Treg

Time frame
At 4 months
3

Expression of markers of blood and skin immunological signaling pathways

Mainly Th1, Th2, Th9, Th17, Th22 and Treg

Time frame
At 1 year
4

Expression of markers of blood T cell populations and skin transcriptomics

Time frame
At inclusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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