Calcitriol 3µg/g Ointment in the Management of Mild to Moderate Plaque Type Psoriasis: Results from 2 Placebo-Controlled, Multicenter, Randomized Double-Blind, Clinical Studies
April 2007 | Volume 6 | Issue 4 | Original Article | 428 | Copyright © April 2007
Mark Lebwohl MD, Alan Menter MD, Jonathan Weiss MD, Scott D. Clark MD, Javier Flores MD, Jerold Powers MD, Arthur K. Balin MD, Steven Kempers MD, Robert J. Glinert MD, Thomas Fleming MD, Yin Liu PhD, Michael Graeber MD, David M. Pariser MD
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 ?g/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 ?g/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 ?g/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 ?g/g ointment and 420
received the vehicle. In both studies, calcitriol 3 ?g/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 ?g/g ointment
demonstrated good systemic and local safety profile comparable to its vehicle with no effect on calcium homeostasis.
Conclusion: Calcitriol 3 ?g/g ointment applied for 8 weeks is effective and safe in the treatment of mild to moderate