Calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris: a randomized, controlled clinical trial

Dermatology. 2011;222(2):148-56. doi: 10.1159/000323408. Epub 2011 Feb 3.

Abstract

Objective: To establish the efficacy and safety of once daily treatment of Daivobet®/Dovobet® gel in patients with psoriasis vulgaris, relative to tacalcitol ointment and the gel vehicle alone.

Methods: 458 patients with at least moderately severe disease were randomized in 3 treatment arms for an 8-week period. Treatment was investigator blinded, and treatment success was defined as patients with an Investigator's Global Assessment of 'clear' or 'almost clear' at week 8.

Results: The proportion of patients who were 'clear or almost clear' was significantly higher in the 2-compound gel group (39.9%) compared with 17.9% in the tacalcitol group and 5.5% in the gel vehicle group: p < 0.001 in both comparisons. The proportion of patients with at least 1 adverse drug reaction was significantly lower in the 2-compound gel group compared to the other 2 treatment groups.

Conclusions: Once-a-day treatment with the 2-compound Daivobet/Dovobet gel is a safe and efficacious therapeutic regimen for individuals with psoriasis on the body.

Publication types

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

MeSH terms

  • Adult
  • Betamethasone / analogs & derivatives*
  • Betamethasone / therapeutic use
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Dermatologic Agents / therapeutic use*
  • Dihydroxycholecalciferols / therapeutic use*
  • Drug Combinations
  • Female
  • Gels
  • Humans
  • Male
  • Middle Aged
  • Ointment Bases
  • Pharmaceutical Vehicles
  • Psoriasis / drug therapy*
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Dermatologic Agents
  • Dihydroxycholecalciferols
  • Drug Combinations
  • Gels
  • Ointment Bases
  • Pharmaceutical Vehicles
  • betamethasone dipropionate, calcipotriol drug combination
  • 1 alpha,24-dihydroxyvitamin D3
  • Betamethasone
  • Calcitriol