Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
Status:
Terminated
Trial end date:
2008-11-01
Target enrollment:
Participant gender:
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.