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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06599411
Acronym
ImmuneSkinBank
Enrollment
830
Registered
2024-09-19
Start date
2025-10-20
Completion date
2045-10-20
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Active Leprosy, Atopic Dermatitis, Autoimmune Bullous Dermatosis, Cutaneaous Scleroderma, Cutaneous Granulomatosis, Cutaneous Lupus, Cutaneous Vasculitis, Dermatomyositis, Hidradenitis Suppurativa, Lichen Planus, Neutrophilic Dermatosis, Psoriasis

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.

Interventions

OTHERSampling

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

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Therapeutic responseAt 1 yearIt is defined as complete or partial remission on the Investigator/Physician Global Assessment (IGA/PGA) scale.

Secondary

MeasureTime frameDescription
Expression of markers of blood and skin immunological signaling pathwaysAt inclusionMainly Th1, Th2, Th9, Th17, Th22 and Treg
Expression of markers of blood T cell populations and skin transcriptomicsAt inclusion
Therapeutic responseAt inclusionBased on markers of blood T cell populations and skin transcriptomics
Microbiota markersAt inclusionIdentification of cluster specific to the pathology, identification of an over-representation of one or more microbiological species. For patients and controls
Proportion of patients suffering from adverse effects of systemic treatmentsAt inclusionAccording to the CTCAE classification and MedDRA
Quality of life measurementAt inclusionThe EPICES score (Evaluation of Deprivation and Inequalities in Health Examination Centers) is an individual measure of social deprivation. The score ranges from 0 to 100, where 0 indicates no deprivation and 100 indicates the highest level of deprivation. Higher EPICES scores reflect greater social deprivation and vulnerability. The Dermatology Life Quality Index (DLQI) is a dermatology-specific questionnaire used to assess the impact of skin disease on a patient's quality of life. The total score ranges from 0 to 30, with higher scores indicating greater impairment in quality of life. The SF-36 v1 is a generic health-related quality-of-life questionnaire that assesses eight domains of physical and mental health. Scores range from 0 to 100 for each domain, with higher scores indicating better health status and quality of life.

Countries

France

Contacts

CONTACTCharles Cassius, MD
charles.cassius@aphp.fr630944832
CONTACTJérôme Lambert, MD PhD
jerome.lambert@u-paris.fr142499742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026