Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2020-12-02
2022-11-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
. It is planned to include 45 patients (15 patients per severity group: SCORAD \]25-50\] , \]50-65\]; 50-65; \>65).The first 20 patients included will be group 2 and 3 patients (SCORAD \> 50).
The patients will be adults with AD recruited from the cohort of patients followed up in the Dermatology department of Nantes University Hospital. A refusal rate of 4/5 is expected. Recruitment can therefore be envisaged in 18 months (2.5 patients/month). Patients will be recruited during follow-up consultations or at the first consultation in the department. Recruitment will be coordinated by the clinical research team (CRT). Blood samples will be taken by the CRT Nurse. The skin and blood samples will be sent to the CIMNA/ Immunology Laboratory Nantes University hospital
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
PARALLEL
OTHER
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Biopsy
All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients affiliated to French social security system
* Patients who gave written consent after reading the protocol
* Moderate to severe AD (SCORAD score\>25)
* Presence of at least one lesional and one non-lesional skin area in the area covered by the clothing
* No immunosuppressive systemic treatment in progress for at least 3 months or biologics for at least 4 months
Exclusion Criteria
* Pregnant and/or breastfeeding women
* Patients under guardianship or tutorship
* Inability to understand information and instructions
* Patients undergoing systemic immunosuppressive treatment for at least 3 months or biologics for at least 4 months
* Patient included in a clinical trial
* Documented allergy to the anesthetic (xylocain)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Plateforme CIMNA, Laboratoire d'Immunologie, Nantes University Hospital
UNKNOWN
UCB Biopharma SRL
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sébastien BARBAROT
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nantes University Hospital
Nantes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC19_0320
Identifier Type: -
Identifier Source: org_study_id