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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT04699695
Eligibility Criteria:
Inclusion Criteria:
1. Males and females at least 1 year of age;
2. Subjects with documented, active moderate to severe atopic dermatitis;
3. Subjects must have a history of atopic dermatitis for at least three months;
4. Subjects with no known reactions to adhesives;
5. Subject has a sufficient number of target plaques on the central body, which includes knees or elbows, and not limited to lesions on the mucosal membranes, soles of the feet or palms of the hands;
6. Subjects willing to follow standard of care (SOC) for his/her atopic dermatitis; and
7. Subjects must be able to complete all study visits required by the protocol.
Exclusion Criteria:
1. Pregnant or breast feeding, including positive pregnancy test at baseline or expected to become pregnant during participation in the trial;
2. History of cancer (exceptions for: a) non-metastatic malignancy deemed cured at the time of enrollment, b) skin cancer that has been excised with controlled margins or has not recurred in 6 months; and c) treated cervical cancer in situ);
3. Current acute infectious illness (viral, parasitic or bacterial) within 4 weeks of enrollment;
4. Receipt of systemic anti-atopic dermatitis medication, including retinoids, corticosteroids, cyclosporine, methotrexate within the four weeks of the Baseline Visit;
5. Use of topical therapy (except emollients) for atopic dermatitis or any other condition within two weeks of the Baseline Visit;
6. Receipt of any investigational drug therapy within four weeks or 5 half-lives, whichever is longer of study enrollment, or concurrent participation in another interventional clinical study; and
7. Documented substance abuse, any other significant medical condition or laboratory result that would indicate an unreasonable risk to the subject or potential interference with study procedures, or would negatively affect the patient's reliability and compliance with the study schedule.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT04699695
Study Brief:
Protocol Section:
NCT04699695