A comparison of the efficacy and safety of the combination mometasone furoate 0.1% salicylic acid 5% ointment with each of its components in psoriasis

A controlled, double-blind, parallel-group, multicenter comparison study enrolled 341 patients with moderate to severe psoriasis. The efficacy and safety of twice-daily application for 3 weeks of the combination ointment mometasone furoate 0.1%/salicylic acid 5% was compared with that of its individual components, mometasone furoate 0.1% ointment and salicylic acid 5% ointment. The severity of erythema, induration, and scaling of preselected target lesions was scored at baseline and days 4, 8, 15, and 22, in addition to the investigator's global evaluation of clinical response of all treated lesions (target and nontarget) at each follow-up visit. Adverse events were monitored and scored at all centers. Changes in routine laboratory values, hypothalamic-pituitary-adrenal (HPA) axis suppression by cosyntropin testing, and salicylic acid blood levels were monitored at two centers. The combination ointment was shown to be statistically significantly more effective than each of its components (P < 0.01). Treatment-related adverse events were 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.