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Characterization of the Cytokine Profile and the Microbiome in Darier's Disease

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Toulouse
NCT06614777 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Darier disease is a rare genetic skin disease caused by mutations in the ATP2A2 gene. Clinically, patients present with inflammatory and keratotic papules, sometimes erosive and oozing, predominating in seborrheic areas and folds. The lesions are very visible, causing itching and pain and a significant impairment of quality of life. Complications such as superinfections of the skin (bacterial and viral) are very common and sometimes severe. Therapeutically, treatments are mainly symptomatic and often of limited effectiveness, particularly on inflammation and pruritus. The main objective of this clinical study is to compare the microbiota of the epidermis of patients with Darier disease in non-lesional areas versus lesional areas , making it possible to identify bacteria/clusters of bacteria, but also to analyze the metabolic pathways of the microbiota associated with the microbial signat

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18 or over, * MD (clinical diagnosis), * MD moderate to severe, * Person affiliated or beneficiary of a social security scheme, * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research). Exclusion Criteria: * Other inflammatory dermatological diseases : atopic dermatitis, psoriasis and lichen planus, * Skin superinfection (clinical diagnosis), * Treatment with a biotherapy, in progress or in the 12 weeks preceding inclusion, * Treatment with oral retinoids introduced in the 6 months preceding inclusion, * Application of tacrolimus to the areas or to more than 30% of the body surface, * Application of topical corticosteroids to the areas or to more than 30% of the body surface, within 2 weeks preceding inclusion, * Oral corticosteroid therapy in the 2 weeks preceding inclusion, * Application of topical retinoids to the areas in the 2 weeks prior to inclusion, * Oral and/or topical antibiotic therapy in the 2 weeks preceding inclusion, * Local antiseptic in the 2 weeks preceding inclusion, * Local keratolytics on areas within 5 days preceding inclusion.
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What it tests

  • skin biopsies and blood extraction
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Where

1 site
University Hospital of Toulouse
Toulouse, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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