ClinicalTrials.gov record NCT06599411

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old and older
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective observational study collecting blood, skin and other samples from people with chronic inflammatory skin diseases and from surgical controls. The study measures immune markers, microbiota and quality-of-life and follows clinical treatment response over time. The main outcome is treatment response at one year measured by the Investigator/Physician Global Assessment (IGA/PGA).

What it is studying. Whether cellular, molecular and microbiological markers in blood, skin and other samples are associated with response to systemic treatments and with drug toxicity, and to improve understanding of disease mechanisms over time.

What the researchers hope to learn. Identify cellular and molecular prognostic factors associated with response to systemic treatments at 1 year; improve understanding of the pathophysiology of chronic inflammatory skin diseases; identify prognostic markers associated with clinical status over up to 10 years; identify markers associated with drug toxicity; and characterize disease-specific microbiota and quality-of-life patterns.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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 being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Sampling

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving informed consent, participants will provide biological samples and clinical information at enrollment and at follow-up time points (including at 4 months, 1 year, and yearly up to 10 years). Sampling may include extra blood draws, a superficial skin biopsy (for patients), skin swabs, hair follicle samples, and stool; controls may instead have preservation of post-operative healthy skin remnants plus blood, swabs, hair and stool samples. Participants will complete quality-of-life questionnaires (EPICES, DLQI, SF-36) and have clinical assessments of disease state and treatment side effects during follow-up. The study is observational — it does not assign treatments; collected samples and data will be analyzed for immune, transcriptomic and microbiota markers and for links with treatment response and toxicity.

How the study is structured. Prospective observational cohort: people with inflammatory skin diseases and healthy surgical controls provide samples (blood, skin biopsy or surgical skin remnant, swabs, hair follicle, stool) at enrollment and at scheduled follow-ups; researchers measure immune markers, transcriptomics, microbiota, adverse effects and quality-of-life repeatedly up to years of follow-up.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under polymyositis.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Oct 20, 2025
Primary completion
Nov 20, 2035 (estimated)
Study completion
Oct 20, 2045 (estimated)
Target enrollment
830 participants (estimated)
Last updated on registry
Jun 12, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique - Hôpitaux de Paris

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
corticosteroid
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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