Pimecrolimus (
Elidel,
SDZ ASM 981), a new macrolactam
ascomycin derivative, was highly effective in treating plaque-type
psoriasis when applied under Finn-chamber occlusion. A two-centre, randomized, double-blind, vehicle- and positive-controlled within-patient study was therefore conducted in 23 adult
psoriasis patients.
Pimecrolimus 1% was applied, twice daily, in an experimental
ointment formulation, along with the corresponding vehicle, 0.005%
calcipotriol ointment and 0.05% clobetasol-17-propionate
ointment to test sites without occlusion for 21 days.
Erythema, induration and scaling (score: 0 [absent] to 4 [severe]) were evaluated. The total sign score was defined as the sum of the
erythema, induration and scaling scores (range 0-12).
Pimecrolimus 1%
ointment was significantly (p = 0.03) more effective than the corresponding vehicle, with an improvement in total sign score of 51.4% compared with 36.7% for the corresponding vehicle. Improvements with
calcipotriol and clobetasol-17-propionate were 71.5% and 88.3%, respectively. No local or systemic
drug-related side effects were observed in the study. We conclude that
pimecrolimus 1% in the experimental
ointment formulation was significantly more effective than its corresponding vehicle, but less effective than
calcipotriol and
clobetasol ointment. This is the first study reporting a significant
therapeutic effect of
pimecrolimus in an
ointment formulation applied without occlusion to psoriatic plaques.