Clinical and cytological effects of pimecrolimus cream 1% after resolution of active atopic dermatitis lesions by topical corticosteroids: a randomized controlled trial.

BACKGROUND

Topical pimecrolimus may maintain remissions of atopic dermatitis (AD) by inhibiting subclinical inflammation.

OBJECTIVE

To evaluate clinical and cytological effects of pimecrolimus in topical corticosteroid-treated and resolved AD lesions.

METHODS

Patients (n=67) with resolved AD lesions were randomized to 3-week double-blind treatment with either pimecrolimus cream 1% or vehicle cream. Outcome measures were reduction in Eczema Area and Severity Index (EASI) and number of leukocytes in skin biopsies in all randomized patients who were evaluable at the end of study.

RESULTS

The proportion of patients with a localized EASI<2 at the end of study was higher with pimecrolimus cream 1% than with vehicle cream (73.5 vs. 39.4%, respectively). There was a significant decrease in the number of infiltrating CD45+ cells in pimecrolimus cream 1% compared with placebo cream (-88.2 vs. 43.2 cells/mm(2), respectively, p=0.047) and a slight but nonsignificant reduction in the number of dermal dendritic cells, Langerhans cells, T cells and macrophages with pimecrolimus versus vehicle cream.

LIMITATIONS

This was an exploratory study.

CONCLUSION

Topical pimecrolimus was effective at maintaining betamethasone-17α-valerate-induced AD remission by inhibiting recurrences of the inflammatory infiltrate in the skin.