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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Sep 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating Darier disease, a rare skin condition caused by a genetic mutation that leads to itchy, painful skin lesions. The study aims to understand the differences in skin bacteria (microbiome) between healthy skin areas and those affected by the disease. By studying these bacteria and their related processes, researchers hope to find new insights that could improve treatment options for patients. The trial will involve 40 adults aged 18 and older who have moderate to severe Darier disease.

To participate, individuals must have a confirmed diagnosis of Darier disease and be willing to provide consent. They should not have other skin conditions like eczema or psoriasis, and must not have used certain skin treatments in the weeks before joining the study. Participants will undergo various tests, including skin samples and blood tests, to help researchers gather the needed information. This study is important because it could lead to better understanding and management of Darier disease, ultimately improving the quality of life for those affected.

Gender

ALL

Eligibility criteria

• 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.