Comparative study of calcipotriol (MC 903) ointment and betamethasone 17-valerate ointment in patients with psoriasis vulgaris

J Am Acad Dermatol. 1992 May;26(5 Pt 1):736-43. doi: 10.1016/0190-9622(92)70103-m.

Abstract

Background: Topical vitamin D analogues have been reported to be an effective treatment in patients with psoriasis. Comparative studies with existing treatments are required.

Objective: Our purpose was to compare the effectiveness of calcipotriol (50 micrograms/gm) and betamethasone 17-valerate (1 mg/gm) ointments twice daily in the treatment of stable plaque psoriasis.

Methods: This study was a randomized, double-blind comparison over 6 weeks in 409 patients. Efficacy, as measured by the Psoriasis Area and Severity Index (PASI), and safety were assessed at 2, 4, and 6 weeks.

Results: Reduction of PASI was statistically significant at all time points for both treatments but there were no significant between-treatment differences. At the completion of 6 weeks of treatment, the mean PASI reduction was 5.50 for calcipotriol and 5.32 for betamethasone (95% confidence interval [CI] -0.40 to 0.78). Analysis of patient assessment at 6 weeks showed clearance or marked improvement in 61.2% of the calcipotriol patients and 50.5% with betamethasone (95% CI 1.4 to 20.8). Calcipotriol produced significantly more local side effects (19.5% compared with 3.9%, p less than 0.001); however, these were minimal leading to withdrawal in only 3 of 205 patients.

Conclusion: Calcipotriol ointment was as effective as betamethasone 17-valerate ointment as measured by the PASI and superior as measured by self-assessment in patients with stable plaque psoriasis. Both treatments were well tolerated.

Publication types

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

MeSH terms

  • Betamethasone Valerate / adverse effects
  • Betamethasone Valerate / therapeutic use*
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Canada
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Drug Tolerance
  • Female
  • France
  • Humans
  • Ireland
  • Male
  • Ointments
  • Patient Dropouts
  • Psoriasis / drug therapy*
  • United Kingdom

Substances

  • Dermatologic Agents
  • Ointments
  • calcipotriene
  • Betamethasone Valerate
  • Calcitriol