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:
NCT02615561
Eligibility Criteria:
Inclusion Criteria:
* Written parents' informed consent to have their child participate in the study and attend the study procedures and processes as outlined in the protocol
* Male or female babies/children aged between 1 month and 4 years
* Mild AD presenting a maximum SCORAD of 25 (at Screening and Baseline)
* Acute flare-up phase
* Local SCORAD ≥ 5 on the target area (at Screening and Baseline)
* Skin type I - IV according to Fitzpatrick
Exclusion Criteria:
* Any other skin disease at the target area that would interfere the clinical assessment in the opinion of the investigator
* Known allergies to any of the ingredients of the IMPs
* Any other adjuvant therapy for AD (UV therapy, probiotics, homeopathy etc.) within 30 days before Baseline as well as during the entire study
* Any use of another topical emollient or other established treatment for AD during Phase 1 (cure phase) and Phase 2 (care phase) at the site of flares (AD lesions). Exception are usual hygienic products in the nappy area
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
4 Years
Study:
NCT02615561
Study Brief:
Protocol Section:
NCT02615561