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Atopic DermatitisImmuneSkinBankNCT06599411

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

An observational study of Atopic Dermatitis and Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Sampling
How many people
830 participants
Where
1 siteFrance
Study dates
20 Oct 2025to 20 Oct 2045
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients affected by inflammatory skin disease and controls

Who may be able to join

  • 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 :
Show all 10Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jérôme Lambert, MD PhD contact

142499742 ext. +33

jerome.lambert@u-paris.fr

France1 site, 1 recruiting
  • Hôpital Saint Louis

    Paris

    Charles Cassius, MD phD, 1 42 49 99 61 ext. +33, charles.cassius@aphp.fr

    Recruiting

Other trials in France

About this study

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

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.

Being tested
Sampling
Medical subject headings
Dermatitis, Atopic, Psoriasis, Hidradenitis Suppurativa, Lichen Planus, Dermatomyositis, Skin Diseases, Vascular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SamplingOther

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

  • SamplingOther

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

Study groups in NCT06599411
Study groupRoleWhat they receive
PatientsAffected by inflammatory skin disease
Receives: Other: Sampling
ControlsPlastic surgery patients who have had any type of surgery resulting in healthy skin remnants
Receives: Other: Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Therapeutic response

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

    Measured: At 1 year

Secondary outcomes (44)
  1. Expression of markers of blood and skin immunological signaling pathways

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

    Measured: At inclusion

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

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

    Measured: At 4 months

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

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

    Measured: At 1 year

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

    Measured: At inclusion

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

    Measured: At 4 months

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

    Measured: At 1 year

  7. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At inclusion

  8. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 4 months

  9. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 1 year

  10. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 2 years

  11. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 3 years

  12. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 4 years

  13. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 5 years

  14. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 6 years

  15. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 7 years

  16. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 8 years

  17. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 9 years

  18. Therapeutic response

    Based on markers of blood T cell populations and skin transcriptomics

    Measured: At 10 years

  19. Microbiota markers

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

    For patients and controls

    Measured: At inclusion

  20. Microbiota markers

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

    For patients only

    Measured: At 1 year

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

    According to the CTCAE classification and MedDRA

    Measured: At inclusion

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

    According to the CTCAE classification and MedDRA

    Measured: At 4 months

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

    According to the CTCAE classification and MedDRA

    Measured: At 1 year

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

    According to the CTCAE classification and MedDRA

    Measured: At 2 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 3 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 4 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 5 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 6 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 7 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 8 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 9 years

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

    According to the CTCAE classification and MedDRA

    Measured: At 10 years

  33. Quality of life measurement

    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.

    Measured: At inclusion

  34. Quality of life measurement

    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.

    Measured: At 4 months

  35. Quality of life measurement

    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.

    Measured: At 1 year

  36. Quality of life measurement

    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.

    Measured: At 2 years

  37. Quality of life measurement

    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.

    Measured: At 3 years

  38. Quality of life measurement

    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.

    Measured: At 4 years

  39. Quality of life measurement

    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.

    Measured: At 5 years

  40. Quality of life measurement

    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.

    Measured: At 6 years

  41. Quality of life measurement

    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.

    Measured: At 7 years

  42. Quality of life measurement

    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.

    Measured: At 8 years

  43. Quality of life measurement

    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.

    Measured: At 9 years

  44. Quality of life measurement

    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.

    Measured: At 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start20 Oct 2025
  3. Primary completion20 Nov 2035 (estimated)
  4. Study completion20 Oct 2045 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
830 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06599411
Sponsor's protocol ID
APHP240183
Acronym
ImmuneSkinBank
Status last verified
Jun 2026
First submitted
13 Sep 2024
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Atopic Dermatitis and Psoriasis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Charles Cassius, MD (630944832 ext. +33, charles.cassius@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Therapeutic response (time frame: At 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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