Analyzing the cytokine profile and microbiome in Darier's Disease
Characterization of the Cytokine Profile and the Microbiome in Darier's Disease: Towards New Therapeutic Perspectives.
This study is testing how the bacteria on the skin and certain immune signals differ between healthy and affected areas in people with Darier's Disease to better understand the condition and find new treatment options.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse, Centre Hospitalier Universitaire de Toulouse) |
| Trial ID | NCT06614777 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the differences in the microbiota of the skin in patients with Darier's Disease by comparing non-lesional and lesional areas. It will involve skin biopsies and blood extraction from participants to analyze the cytokine profiles and microbial signatures associated with the disease. The study builds on previous findings that suggest a correlation between specific bacteria and the severity of skin lesions in Darier's Disease. By understanding these relationships, the research hopes to shed light on the underlying mechanisms of inflammation and potential therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and over with a clinical diagnosis of moderate to severe Darier's Disease.
Not a fit: Patients with other inflammatory skin conditions or those currently undergoing specific treatments that may interfere with the study will not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for managing inflammation and skin lesions in patients with Darier's Disease.
How similar studies have performed: Previous studies have shown promising results in understanding the microbiome and cytokine profiles in related skin conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toulouse, Centre Hospitalier Universitaire de Toulouse
- University Hospital of Toulouse — Toulouse, Centre Hospitalier Universitaire de Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Juliette Mazereeuw-hautier, MD — University Hospital of Toulouse
- Study coordinator: Nadège ALGANS, PM
- Email: algans.n@chu-toulouse.fr
- Phone: 0561777204
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.