RecruitingNot Applicable

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

France830 participantsStarted 2025-10-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is collecting skin and blood samples to find biomarkers that predict who responds to systemic treatments — does my specific condition, whether it's atopic dermatitis, psoriasis, or one of the other listed diseases, fit what they're actively enrolling right now?
2Since this trial isn't testing a new drug but rather observing how I respond to whatever systemic treatment my care team already plans for me, does participating change my treatment plan at all, or would I just be providing extra samples alongside my normal care?
3What does the sample collection actually involve — how many skin biopsies or blood draws would I need, how often, and over what period of time, and is that realistic given my current health and schedule?
4Because this is a biomarker discovery study rather than a treatment trial, what direct benefit, if any, might I personally get from participating, versus how might my data help future patients with inflammatory skin diseases?
5Are there any risks specific to the skin biopsy procedures involved in this study that I should weigh against the potential contribution to research, especially if my skin condition is already causing open wounds or lesions?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Therapeutic response

Timeframe: At 1 year

Trial details

NCT IDNCT06599411

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2035-11-20

Contact for this trial

Charles Cassius, MD

630944832 charles.cassius@aphp.fr

View on ClinicalTrials.gov More Atopic Dermatitis trials