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 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT00996008
Eligibility Criteria:
Inclusion Criteria:
* Male and Female subjects aged \>18 year
* Written informed consent
* Mild to moderate AD at baseline (EASI score of at least 2 or 3)
* Active AD (visible eczema, erythema and pruritus)
* Presence of at least four target lesions (symmetrically) at inclusion (ideally at the elbow flexions and knee bends)
Exclusion Criteria:
* If female of childbearing potential not using an adequate and appropriate form of contraception such as oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch
* If female, are pregnant or lactating, or intend to become pregnant during the study period
* Allergy to test drug or excipients
* Usage of topical corticosteroids or other topical treatments for AD within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment
* Within 4 weeks prior to study entry, have received systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidals, immunosuppressants, or immunomodulating drugs, or treatment with light).
* Presence of major medical illness requiring systemic therapy including cancers
* Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses
* Any clinical relevant ECG abnormality
* Have any clinically significant abnormal clinical laboratory test results at screening
* Received any investigational drug or taking part in any clinical study within three months prior to this study
* History of drug, alcohol or other substance abuse or other factors limiting the ability to co-operate and to comply with this protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00996008
Study Brief:
Protocol Section:
NCT00996008