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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT00510003
Eligibility Criteria:
Inclusion Criteria:
* Male or female.
* Age: between 2 - 12 years.
* Outpatients with diagnosis of atopic dermatitis
* Atopic dermatitis affecting ≥ 5% of Total Body Surface Area at Baseline Investigator's Global Assessment score of 2 (mild) or 3 (moderate).
* Baseline visit pruritus (itching) severity assessment score of 2 (moderate) or 3 (severe).
* Patients or patient's legal guardian who has been informed of the study procedures and has signed the informed consent form approved for the study prior to starting any study related procedures, including washout (in case that it would be necessary).
Exclusion Criteria:
* Patients being breast-fed by women receiving systemic or prohibited medication.
* Children with known hypersensitivity to study medication.
* Children who received phototherapy or systemic therapy (immunosuppressants, cytostatics) known to affect atopic dermatitis within the previous month or topical therapy (tar, topical corticosteroids), systemic corticosteroids, systemic antibiotics or leukotriene antagonists within the previous week.
* Children who received investigational drugs within 8 weeks prior to first application of study medication.
* Children who had concurrent skin disease or active bacterial, viral or fungal infection.
* Immunocompromised children (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or children with a history of malignant disease.
Other protocol-defined inclusion/exclusion criteria may apply.
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT00510003
Study Brief:
Protocol Section:
NCT00510003