A randomized multicentre, parallel group, double-blind, vehicle-controlled study to evaluate the efficacy and safety of 1% SDZ ASM 981 cream in the long-term management of atopic dermatitis in children from 3 months to 23 months of age

Abstract

SDZ ASM 981 is a novel ascomycin macrolactam derivative developed for the treatment of inflammatory skin disease − especially atopic dermatitis. It specifically inhibits the release of inflammatory cytokines from T cells and has been formulated for topical use as a 1% cream. In order to assess the long-term safety and efficacy in children 3 months to 23 months of age, a multicentre, parallel group, double-blind vehicle-controlled 1-year study has been performed. Thirty-nine investigators in seven countries recruited 250 patients aged between 3 months and 23 months with a diagnosis of atopic dermatitis based on the criteria of Williams et al. These patients were randomized to either 1% SDZ ASM 981 cream [Eldel™ (pimecrolimus)] or corresponding vehicle cream (4 : 1 Elidel™: control allocation), to he applied to all affected areas. Treatment was twice a day according to need. Medium high potency topical corticosteroid was allowed as second-line medication to control refractory flares. After acute control of the flare the patient reverted to study medication to maintain control of the disease. Disease management is defined as controlling atopic dermatitis by treating early signs and symptoms with 1% SDZ ASM cream in order to prevent exacerbation to an extent that treatment with a second-line topical corticosteroid medication is required. Primary efficacy analysis was conducted on the frequency of flares observed. In addition, clinical signs and symptoms were recorded using the Eczema Area and Severity Index (EASI) subject assessment, Investigator's Global Assessment and pruritus severity assessment. Adverse events and local tolerability were also recorded. The Study demonstrated the efficacy of Elidel™ (pimecrolimus) vs. control. There was a statistically significant decrease in the number of flares in the Elidel™ group compared with control. A rapid and sustained improvement in pruritis and a significant reduction in EASI scores were also observed in the Elidel™ group. The requirement for a moderately potent topical steroid in the Elidel™ group was decreased as compared with the control group. Adverse events in both groups were similar with no significant systemic event. Infection − bacterial and viral − including the normal childhood illnesses, was similar in the two groups and application site adverse events were also similar in the two groups.