Conditions: Atopic Dermatitis
Keywords: Atopic, dermatitis, asthma, children, modification Atopic dermatitis/atopy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1091
Healthy volunteers: no

Brief summary:
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a conventional corticosteroid-based treatment (1:1 ratio), followed by a 2 to 3-year open-label (OL) phase (all patients receiving pimecrolimus cream 1% LTM). At the end of the double-blind phase, the two treatment groups will be compared with respect to their efficacy in controlling AD; at the end of the OL phase, the incidence of asthma at the age of 6 years will be compared.

Detailed description:

Arms:
arm 1: Pimecrolimus arm 2: Corticosteroid

Interventions: intervention 1: Pimecrolimus intervention 2: Corticosteroid
Intervention descriptions: intervention 1: Pimecrolimus cream 1 % intervention 2: conventional corticosteroid-based treatment

Protocol document: