Actively Recruiting
Characterization of the Cytokine Profile and the Microbiome in Darier's Disease
Led by University Hospital, Toulouse · Updated on 2024-12-11
40
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Toulouse
Lead Sponsor
I
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 signature, until now not described. The secondary objectives envisaged are to study the correlation between this microbiotic profile and both the clinical characteristics of patients and the cytokine profile. The research will be performed on 40 patients aged 18 or over, suffering from moderate to severe Darier Disease. For each patient, several samples will be collected including biopsies, blood sample, swabbing and tape-stripping, on lesional and non-lesional areas.
CONDITIONS
Official Title
Characterization of the Cytokine Profile and the Microbiome in Darier's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or over
- Clinical diagnosis of Darier disease
- Moderate to severe Darier disease
- Affiliated with or beneficiary of a social security scheme
- Signed free, informed, and written consent before any study examination
You will not qualify if you...
- Presence of other inflammatory skin diseases such as atopic dermatitis, psoriasis, or lichen planus
- Skin superinfection diagnosed clinically
- Current or recent biotherapy treatment within 12 weeks before inclusion
- Oral retinoid treatment within 6 months before inclusion
- Use of tacrolimus on study areas or more than 30% of body surface
- Use of topical corticosteroids on study areas or more than 30% of body surface within 2 weeks before inclusion
- Oral corticosteroid therapy within 2 weeks before inclusion
- Use of topical retinoids on study areas within 2 weeks before inclusion
- Oral or topical antibiotic therapy within 2 weeks before inclusion
- Use of local antiseptics within 2 weeks before inclusion
- Use of local keratolytics on study areas within 5 days before inclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Toulouse
Toulouse, Centre Hospitalier Universitaire de Toulouse, France, 31059
Actively Recruiting
Research Team
N
Nadège ALGANS, PM
CONTACT
H
Hélène TEXIER-GERNE, PM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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