"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
The contribution to efficacy of individual components of the vehicle has not been established.
Mechanism of Action
The systemic exposure of calcitriol was assessed in subjects with chronic, plaque psoriasis. In the pivotal pharmacokinetic/pharmacodynamic study, calcitriol ointment 3 mcg/g, was applied twice daily for 21 days (for a total dose of 30 g/day) to 35% of the body surface area (psoriatic + surrounding healthy skin) of subjects with at least 25% of body surface area involvement. At Day 21, the geometric mean plasma concentration values of Cmax increased by approximately 36% over baseline and the geometric mean value of AUC(0 – 12 hr) increased by 44%. There was no correlation between the elevated calcitriol levels and the pharmacodynamic parameters of serum albumin adjusted calcium, serum phosphorus, urinary calcium and urinary phosphorus.
In two, multicenter, double-blind, vehicle-controlled studies, a total of 839 subjects with psoriasis rated “mild” or “moderate” using an investigator global assessment scale were treated twice daily for 8 weeks. Subjects were randomized in a 1:1 ratio to receive either VECTICAL (calcitriol ointment) Ointment or vehicle ointment. The mean age of the subjects was 48 years and 66% were male; most subjects were rated “moderate” at baseline.
Success was defined as “Clear or Minimal”(up to light red or pink in coloration, surface dryness with some white coloration, and slight elevation above normal skin) with at least a 2-grade change from baseline. The success rates are displayed in the table.
Percentage of Subjects with Clear or Minimal Disease AND Two Grade Improvement at End of Treatment (8 weeks)
|Study 1||Study 2|
Last reviewed on RxList: 3/10/2009
This monograph has been modified to include the generic and brand name in many instances.
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