A COMPARISON OF THE EFFICACY AND SAFETY OF THE COMBINATION MOMETASONEFUROATE 0.1-PERCENT SALICYLIC-ACID 5-PERCENT OINTMENT WITH EACH OF ITS COMPONENTS IN PSORIASIS

A controlled, double-blind, parallel-group, multicenter comparison stu dy enrolled 341 patients with moderate to severe psoriasis. The effica cy and safety of twice-daily application for 3 weeks of the combinatio n ointment mometasone furoate 0.1%/salicylic acid 5% was compared with that of its individual components, mometasone furoate 0.1% ointment a nd salicylic acid 5% ointment. The severity of erythema, induration, a nd scaling of preselected target lesions was scored at baseline and da ys 4, 8, 15, and 22, in addition to the investigator's global evaluati on of clinical response of all treated lesions (target and nontarget) at each follow-up visit. Adverse events were monitored and scored at a ll centers. Changes in routine laboratory values, hypothalamic-pituita ry-adrenal (HPA) axis suppression by cosyntropin testing, and salicyli c acid blood levels were monitored at two centers. The combination oin tment was shown to be statistically significantly more effective than each of its components (P < 0.01). Treatment-related adverse events we re few and mostly of mild to moderate severity. No significant changes in laboratory values were observed; blood salicylic acid levels were unchanged, and there was no HPA axis suppression observed with any of the treatments.