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 @ 7:09 PM
Ignite Modification Date:
2025-12-24 @ 7:09 PM
NCT ID:
NCT00484003
Eligibility Criteria:
Inclusion Criteria:
* Male or female
* Age ≥2 years ≤12 years of age
* Atopic dermatitis on sensitive skin areas only ( i.e. face , neck and flexures )
* Subjects in whom other treatment modalities are inadvisable according to the investigator's clinical opinion or have failed on other treatment modalities due to intolerance or inadequate response.
* Patients with a history of mild to moderate AD
* Subjects should present at visit 1 with a clear clinical diagnosis of mild to moderate AD.
* Subject's parents or legal guardian must have been informed of the study procedures and must have signed the Informed Consent form approved for the study prior to any study related procedures
Exclusion Criteria:
* Subjects who have active viral infections at the site(s) of treatment. In the presence of other dermatological infections, the use of appropriate antimicrobial agents should be instituted.
* Subjects who present with systemic malignancy or active lymphoproliferative diseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).
* Subjects who present with clinical conditions other than AD that can, in the opinion of the investigator, interfere with the evaluation
* Subjects who are receiving photo-therapy (e.g., PUVA, UVB) or immunosuppressive therapy (e.g., cyclosporine, FK-506 \[tacrolimus\]).
* Subjects who have used investigational drugs within 8 weeks prior to first application of study medication or intended use of other investigational drugs during the course of this study.
* Subjects who have used, or are using 0.03% or 0.1% tacrolimus ointment.
* Pimecrolimus cream 1% is contraindicated in subjects who have known or suspected hypersensitivity to pimecrolimus or any components of the cream
* Subjects not medically stable or subjects with any condition which, in the opinion of the investigator, should render the subject ineligible for the study.
* Pregnancy and lactation (if applicable)
* Pimecrolimus cream 1% should not be used during pregnancy or lactation
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
12 Years
Study:
NCT00484003
Study Brief:
Protocol Section:
NCT00484003