Psoriasis is a noncontagious skin condition that produces red, dry plaques of thickened skin. The dry flakes and skin scales are thought to result from the rapid proliferation of skin cells that is triggered by abnormal lymphocytes from the blood . Psoriasis commonly affects the skin of the elbows, knees, and scalp.
Some people have such mild ps...
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The contribution to efficacy of individual components of the vehicle has not been established.
The mechanism of action of calcitriol in the treatment of psoriasis has not been established.
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 | ||
| VECTICAL Ointment (N=209) |
Vehicle Ointment (N=209) |
VECTICAL Ointment (N=210) |
Vehicle Ointment (N=211) |
| 23.4% | 14.4% | 20.5% | 6.6% |
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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