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NCT Number: NCT06599411

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

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.

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Key information

Conditions

Atopic Dermatitis Active Leprosy Autoimmune Bullous Dermatosis Bacterial Infections Bacterial Infections and Mycoses Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Cutaneaous Scleroderma Cutaneous Granulomatosis Cutaneous Lupus Cutaneous Vasculitis Dermatitis Dermatitis, Atopic Dermatomyositis Genetic Diseases, Inborn Hidradenitis Hidradenitis Suppurativa Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lichen Planus Lichenoid Eruptions Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases Neutrophilic Dermatosis Polymyositis Psoriasis Skin Diseases Skin Diseases, Bacterial Skin Diseases, Eczematous Skin Diseases, Genetic Skin Diseases, Infectious Skin Diseases, Papulosquamous Skin Diseases, Vascular Skin and Connective Tissue Diseases Suppuration Sweat Gland Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Saint Louis

Paris, France

Location status: Recruiting

Location contact

Charles Cassius, MD phD

CONTACT

[email protected]

1 42 49 99 61 ext. +33

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sampling

Other

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

Primary outcomes

  1. Therapeutic response

    Time frame: At 1 year

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

Secondary outcomes

  1. Expression of markers of blood and skin immunological signaling pathways

    Time frame: At inclusion

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

  2. Expression of markers of blood and skin immunological signaling pathways

    Time frame: At 4 months

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

  3. Expression of markers of blood and skin immunological signaling pathways

    Time frame: At 1 year

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

  4. Expression of markers of blood T cell populations and skin transcriptomics

    Time frame: At inclusion

  5. Expression of markers of blood T cell populations and skin transcriptomics

    Time frame: At 4 months

  6. Expression of markers of blood T cell populations and skin transcriptomics

    Time frame: At 1 year

  7. Therapeutic response

    Time frame: At inclusion

    Based on markers of blood T cell populations and skin transcriptomics

  8. Therapeutic response

    Time frame: At 4 months

    Based on markers of blood T cell populations and skin transcriptomics

  9. Therapeutic response

    Time frame: At 1 year

    Based on markers of blood T cell populations and skin transcriptomics

  10. Therapeutic response

    Time frame: At 2 years

    Based on markers of blood T cell populations and skin transcriptomics

  11. Therapeutic response

    Time frame: At 3 years

    Based on markers of blood T cell populations and skin transcriptomics

  12. Therapeutic response

    Time frame: At 4 years

    Based on markers of blood T cell populations and skin transcriptomics

  13. Therapeutic response

    Time frame: At 5 years

    Based on markers of blood T cell populations and skin transcriptomics

  14. Therapeutic response

    Time frame: At 6 years

    Based on markers of blood T cell populations and skin transcriptomics

  15. Therapeutic response

    Time frame: At 7 years

    Based on markers of blood T cell populations and skin transcriptomics

  16. Therapeutic response

    Time frame: At 8 years

    Based on markers of blood T cell populations and skin transcriptomics

  17. Therapeutic response

    Time frame: At 9 years

    Based on markers of blood T cell populations and skin transcriptomics

  18. Therapeutic response

    Time frame: At 10 years

    Based on markers of blood T cell populations and skin transcriptomics

  19. Microbiota markers

    Time frame: At inclusion

    Identification of cluster specific to the pathology, identification of an over-representation of one or more microbiological species.

    For patients and controls

  20. Microbiota markers

    Time frame: At 1 year

    Identification of cluster specific to the pathology, identification of an over-representation of one or more microbiological species.

    For patients only

  21. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At inclusion

    According to the CTCAE classification and MedDRA

  22. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 4 months

    According to the CTCAE classification and MedDRA

  23. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 1 year

    According to the CTCAE classification and MedDRA

  24. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 2 years

    According to the CTCAE classification and MedDRA

  25. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 3 years

    According to the CTCAE classification and MedDRA

  26. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 4 years

    According to the CTCAE classification and MedDRA

  27. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 5 years

    According to the CTCAE classification and MedDRA

  28. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 6 years

    According to the CTCAE classification and MedDRA

  29. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 7 years

    According to the CTCAE classification and MedDRA

  30. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 8 years

    According to the CTCAE classification and MedDRA

  31. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 9 years

    According to the CTCAE classification and MedDRA

  32. Proportion of patients suffering from adverse effects of systemic treatments

    Time frame: At 10 years

    According to the CTCAE classification and MedDRA

  33. Quality of life measurement

    Time frame: At inclusion

    The 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.

  34. Quality of life measurement

    Time frame: At 4 months

    The 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.

  35. Quality of life measurement

    Time frame: At 1 year

    The 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.

  36. Quality of life measurement

    Time frame: At 2 years

    The 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.

  37. Quality of life measurement

    Time frame: At 3 years

    The 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.

  38. Quality of life measurement

    Time frame: At 4 years

    The 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.

  39. Quality of life measurement

    Time frame: At 5 years

    The 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.

  40. Quality of life measurement

    Time frame: At 6 years

    The 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.

  41. Quality of life measurement

    Time frame: At 7 years

    The 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.

  42. Quality of life measurement

    Time frame: At 8 years

    The 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.

  43. Quality of life measurement

    Time frame: At 9 years

    The 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.

  44. Quality of life measurement

    Time frame: At 10 years

    The 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charles Cassius, MD

CONTACT

[email protected]

630944832 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ImmuneSkinBank

Important dates

Study start
2025
Primary completion
2035
Study completion
2045
First posted
Sep 19, 2024
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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