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:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
NCT ID:
NCT05006300
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged between 3 months and 17 years old;
2. Female or male subjects;
3. Subjects of Caucasian origin with skin type I to IV according to the Fitzpatrick scale
4. Subject with atopic background and mild to moderate signs of atopic dermatitis on the face and/or the body - 5\<SCORAD\<40 \[2\] - with or without dust mite sensitivity;
5. Subject who had at least one atopic dermatitis flare-up in the month prior to the study;
6. Subject with dry to very dry skin on the face and the body;
7. Subject who used a topical corticosteroid - class 2 or 3 - during a flare-up in the month prior to the study;
8. Subject regularly using an emollient in the management of atopic dermatitis;
9. Subject agreeing not to expose to sunlight or artificial UV rays during the study period;
10. Subject who, in the Investigator's opinion, will comply with the requirements of the protocol (e.g., follow protocol instructions, have regular contact to allow evaluation during the study);
11. Subject agreeing not to use any other facial or body care product during the study period, except study products and their usual emollient;
12. Subject agreeing not to use any face or body care products 24 hours prior to the start of the study;
13. Subject agreeing not to use hygiene products with a moisturizing, nourishing, or anti-drying effect during the study period and at least 24 hours before the start of the study;
14. Subject agreeing not to carry out an oral corticosteroid treatment during the entire study period;
15. Patients whose legal guardian has given written consent for their participation in the study;
16. Subject related to the Social Security of a parent or legal guardian in agreement with the French law on interventional research.
Exclusion Criteria:
1. Subject has known or suspected allergies or sensitivities to any of the constituents of the test product (see Product labels);
2. Subject has a medical condition or is taking medication that could put him or her at undue risk;
3. Subject has an unstable medical condition or one that could interfere with the study;
4. Subject who has not received any topical corticosteroids in the month prior to the start of the study;
5. Subject who received oral corticosteroids during the three months before the start of the study;
6. Subject who received oral immunosuppressive drugs during the three months prior to the start of the study;
7. Subject who received local immunosuppressants during the month prior to the start of the study;
8. Subject who received antihistamines during the week prior to the start of the study;
9. Subject having an underlying known disease, or surgical, physical, or medical condition that, in the opinion of the Investigator might interfere with the interpretation of the clinical trial results such as:
* History of other recurrent dermatologic conditions (e.g., psoriasis, eczema, urticarial, and/or hives);
* Any systemic, local disease or skin condition (i.e., active cutaneous diseases; scars, moles, excessive hair, non-flat area, sunburn, uneven skin coloration or other blemishes) on the body;
10. Subject is currently receiving treatment that may interfere, in the opinion of the Investigator, with interpretation of the study results;
11. Subjects taking part in another study or being excluded from a previous study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
17 Years
Study:
NCT05006300
Study Brief:
Protocol Section:
NCT05006300