Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06983561
Eligibility Criteria:
Inclusion Criteria:
Criteria related to the population:
* Subject aged between 18 and 75 years included
* Subject having signed his/her written informed consent for his/her participation in the study
* Subject affiliated to a social security system or health insurance, or is a beneficiary (if required by national regulations
* Subject with appropriate hardware (smartphone and/or tablet and/or computer) to complete digital questionnaires
* Subject with a mailbox and internet access to create his account to complete digital questionnaires
Criteria related to the disease and treatment:
• Subject with moderate to severe atopic dermatitis controlled by systemic treatment, meaning:
* Using systemic treatment for atopic dermatitis (biologics, janus kinase inhibitors or conventional immunosuppressants) initiated for at least 6 months at the time of the inclusion visit
* With an unchanged systemic treatment dose for at least 2 months at the time of the inclusion visit,
* And with an vIGA-ADTM ≤ 2 (Mild).
Non Inclusion criteria:
Criteria related to the population:
* Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing and to report required information in writing in the questionnaire
* For woman of childbearing potential: pregnant or breastfeeding or planning to be pregnant during the study
* Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
* Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
* Subject who is currently participating, who plans to participate or who has participated within the previous weeks or months in another clinical study liable to interfere with the study assessments according to the investigator's assessment
* Subject is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician,…), of the investigational site
Criteria related to the diseases / skin condition:
• Subject having a dermatological condition, an acute, chronic or progressive disease or history of disease liable to interfere with the study data or considered by the Investigator hazardous for the subject or incompatible with the study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06983561
Study Brief:
Protocol Section:
NCT06983561