Topical formulations of pimecrolimus cream have been shown to be effective in atopic dermatitis, chronic irritant hand dermatitis, allergic contact dermatitis, and also in psoriasis, but in this case, under semi-occlusive conditions. Pharmacokinetic studies with pimecrolimus cream 1% indicate a consistently low systemic exposure in infants, children and adults with atopic dermatitis regardless of the extent of lesions treated and of the duration of therapy. These results support the twice daily administration of pimecrolimus cream in long-term use on an as needed basis, with no limitation on the duration of treatment and on the extent of skin surface area treated. The pimecrolimus cream 1% and the corresponding vehicle were devoid of significant irritation, contact sensitization, phototoxic, or photoallergic potential, in the standard local tolerability studies in healthy volunteers.