CALCIPOTRIENE OINTMENT 0.005-PERCENT FOR PSORIASIS - A SAFETY AND EFFICACY STUDY

Background: Plaque psoriasis of mild to moderate severity is routinely treated with topical steroids and coal tar along with emollients. A s afe and convenient new treatment modality would be of value to most pa tients with psoriasis. Objective: Our purpose was to evaluate the safe ty and efficacy of a new vitamin D-3 analogue, calcipotriene, for the treatment of plaque psoriasis. Methods: Twice-daily dosing of calcipot riene was compared with its vehicle, for up to 8 weeks, in a double-bl ind study of 277 patients at 10 study centers in the United States. Tw o hundred forty-seven patients completed the trial. The clinical chara cteristics of plaque elevation, erythema, scaling, and overall disease severity were evaluated at baseline and after 1, 2, 4, 6, and 8 weeks of treatment. A Physician's Global Assessment of improvement or worse ning of the disease was performed after 1, 2, 4, 6, and 8 weeks of tre atment. Blood and urine samples, for routine clinical laboratory tests , were collected at baseline and after 1, 2, 4, and 8 weeks of treatme nt. Results: As early as the week 1 evaluation, patients treated with calcipotriene ointment 0.005% had significantly lower mean scores (p = 0.043) than the vehicle-treated patients for the disease characterist ics of plaque elevation, erythema, and scaling. This trend continued t hrough week 8 of treatment when 70% of the calcipotriene-treated patie nts showed 75% or more improvement compared with only 19% of vehicle-t reated patients. Only minor treatment-related adverse events were obse rved. There were no abnormal laboratory results judged related to trea tment and the rare instances of elevated serum calcium values were equ ally distributed between active and vehicle treatments. Conclusion: Th is study provides evidence that calcipotriene is a safe, effective, an d promising new agent for the treatment of moderately severe plaque ps oriasis.