Calcitriol 3 microg/g ointment in the management of mild to moderate plaque type psoriasis: results from 2 placebo-controlled, multicenter, randomized double-blind, clinical studies.

BACKGROUND: Psoriasis is a chronic skin disorder affecting approximately 2% of the US population. Psoriasis may occur anywhere on the body with initial presentation usually seen between 15 and 30 years of age. Calcitriol 3 microg/g ointment has demonstrated good clinical efficacy as well as topical and systemic safety when used to treat psoriasis. OBJECTIVES: To confirm the efficacy and safety of calcitriol 3 microg/g ointment versus its vehicle in the treatment of subjects with mild to moderate chronic plaque psoriasis. METHODS: Suitable subjects were randomized to receive either calcitriol 3 microg/g ointment or its vehicle twice daily for up to 8 weeks in 2 multicenter, randomized, vehicle-controlled, double-blind parallel group studies. Efficacy was evaluated through a Global Severity Score dichotomized in success (clear and minimal) or failure. Erythema, plaque elevation, scaling and dermatologic sum score (sum of the scores for erythema, plaque elevation, and scaling), pruritus, and global improvement were also assessed. Routine safety and clinical laboratory parameters, including calcium homeostasis, were evaluated throughout the study. RESULTS: In total, 839 subjects were included in the 2 studies: 419 patients received calcitriol 3 microg/g ointment and 420 received the vehicle. In both studies, calcitriol 3 microg/g ointment was shown to be significantly more effective than its vehicle, with onset of therapeutic effect seen as early as week 2 and sustained at all subsequent visits. Calcitriol 3 microg/g ointment demonstrated good systemic and local safety profile comparable to its vehicle with no effect on calcium homeostasis. CONCLUSION: Calcitriol 3 microg/g ointment applied for 8 weeks is effective and safe in the treatment of mild to moderate psoriasis.