A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis

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 theinvestigator's clinical opinion or have failed on other treatment modalities due tointolerance 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 moderateAD.

• Subject's parents or legal guardian must have been informed of the study proceduresand must have signed the Informed Consent form approved for the study prior to anystudy related procedures

Exclusion Criteria:

• Subjects who have active viral infections at the site(s) of treatment. In the presenceof other dermatological infections, the use of appropriate antimicrobial agents shouldbe instituted.

• Subjects who present with systemic malignancy or active lymphoproliferativediseases/disorders (e.g., lymphoma, neoplastic disease, chronic lymphoproliferation).

• Subjects who present with clinical conditions other than AD that can, in the opinionof the investigator, interfere with the evaluation

• Subjects who are receiving photo-therapy (e.g., PUVA, UVB) or immunosuppressivetherapy (e.g., cyclosporine, FK-506 [tacrolimus]).

• Subjects who have used investigational drugs within 8 weeks prior to first applicationof study medication or intended use of other investigational drugs during the courseof 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 suspectedhypersensitivity to pimecrolimus or any components of the cream

• Subjects not medically stable or subjects with any condition which, in the opinion ofthe 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