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 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT04226092
Eligibility Criteria:
Inclusion Criteria:
1. Parent guardian must be able to understand and provide informed consent and participant provide assent as applicable per Institutional Review Board (IRB) guidelines and regulations.
2. Male or female, less than or equal to 3 years of age inclusive at Screening
3. Active AD using Standard Diagnostic Criteria (AAD criteria, Eichenfield et al, 2014). Participant must have an area of non-lesional AD (EASI of 0) within 5 cm. of the measured lesional area within the same region. Participant must have lesional and nonlesional areas of at least 3 cm in diameter to allow for both devices to be tested in contiguous areas OR FOR HEALTHY CONTROLS
4. Participant must meet all of the following criteria:
1. No personal history or current manifestations of AD; no current food allergy, asthma, allergic rhinitis (based on self-report)
2. No evidence of dry skin or other skin issue (EASI score of 0)
Exclusion Criteria:
1. Inability or unwillingness of a parent guardian to give written informed consent, or participant to give assent, if applicable, or to comply with study protocol
2. Who have any skin disease other than AD that might compromise the stratum corneum barrier in infants and young children (e.g., ichthyosis, psoriasis, extensive seborrheic dermatitis, scabies)
3. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.
4. Use of any topical product (e.g., emollient, topical corticosteroids, topical immunomodulatory agents, topical antibiotics) on extremity for testing within 2 hours of the Enrollment Visit.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
3 Years
Study:
NCT04226092
Study Brief:
Protocol Section:
NCT04226092