Efficacy and safety of calcipotriol (MC 903) ointment in psoriasis vulgaris. A randomized, double-blind, right/left comparative, vehicle-controlled study

J Am Acad Dermatol. 1992 Dec;27(6 Pt 1):983-8. doi: 10.1016/0190-9622(92)70299-u.

Abstract

Background: The biologically active form of vitamin D3, calcitriol, may offer a new therapeutic approach to psoriasis. Calcipotriol, a new vitamin D3 analogue, is at least 100 times less calcemic than calcitriol.

Objective: Our purpose was to study the efficacy and safety of calcipotriol in the treatment of psoriasis vulgaris.

Methods: In a right/left comparative, double-blind study, treatment with calcipotriol ointment (50 micrograms/gm) twice daily and placebo was given for 4 weeks. The preferred treatment was continued, without opening the code, for another 4 weeks. Efficacy, as measured by the Psoriasis Area and Severity Index and by the investigator's and patient's global assessment, and safety were assessed every 2 weeks.

Results: The mean Psoriasis Area and Severity Index fell in 4 weeks from 14.2 to 6.3 with calcipotriol and from 14.1 to 9.2 with placebo (p < 0.001; 95% confidence interval for difference: 1.78-->3.94). Local side effects were equally common with calcipotriol and placebo. The mean serum calcium remained unchanged.

Conclusion: Topical application of up to 50 gm of calcipotriol ointment per week was found to be an effective and safe treatment of psoriasis vulgaris.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Calcitriol / administration & dosage
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Ointments
  • Psoriasis / drug therapy*

Substances

  • Dermatologic Agents
  • Ointments
  • calcipotriene
  • Calcitriol