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 @ 3:17 PM
Ignite Modification Date:
2025-12-24 @ 3:17 PM
NCT ID:
NCT04740892
Eligibility Criteria:
Inclusion Criteria:
For Child
* Fitzpatrick skin type I to VI
* Child must have at least 1 target lesion based on the atopic dermatitis severity index (ADSI) with a score of 2-12 and an erythema sub score of at least 2 (moderate)
* Has mild to moderate atopic dermatitis (as per Rajka-Langeland Severity Index; graded as 3.0 to 7.5 inclusive)
* Child must have parent-assessed history of itch
* Has parent-perceived sensitive skin For Parents
* Willing to undergo a 3-day washout period prior to the baseline assessments. During this run-in period, parents will be asked to refrain from using prescription and over-the-counter (OTC) eczema treatments on their child; Acute rescue treatment will be permitted (type of rescue treatment will be determined by principal investigator \[PI\])
* Has signed the informed consent document (ICD), including Health Insurance Portability and Accountability Act (HIPAA) disclosure
Exclusion Criteria:
* Has known allergies or adverse reactions to common topical skincare products or ingredients of the investigational products (IPs)
* Has a history of a confirmed or suspected coronavirus disease 2019 (COVID-19) infection within 30 days prior to Visit 1 For Child
* Presents with a skin condition that may influence the outcome of the study (specifically psoriasis or active skin cancer)
* Severe atopic dermatitis (AD) as determined by the Rajka-Langeland Severity Index For Parent
* Is self-reported to be pregnant or planning to become pregnant during the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
72 Months
Study:
NCT04740892
Study Brief:
Protocol Section:
NCT04740892