Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study

J Dermatolog Treat. 2016;27(2):120-7. doi: 10.3109/09546634.2015.1083935. Epub 2015 Oct 7.


Background: An aerosol foam formulation of fixed combination calcipotriene 0.005% (as hydrate; Cal) plus betamethasone dipropionate 0.064% (BD) was developed to improve psoriasis treatment.

Objectives: To compare the efficacy and safety of Cal/BD aerosol foam with Cal/BD ointment after 4 weeks.

Methods: In this Phase II, multicenter, investigator-blind, 4-week trial, adult patients with psoriasis vulgaris were randomized to Cal/BD aerosol foam, Cal/BD ointment, aerosol foam vehicle or ointment vehicle (3:3:1:1). The primary efficacy endpoint was the proportion of patients at week 4 who achieved treatment success (clear or almost clear with at least a two-step improvement) according to the physician's global assessment of disease severity.

Results: In total, 376 patients were randomized. At week 4, significantly more patients using Cal/BD aerosol foam achieved treatment success (54.6% versus 43.0% [ointment]; p = 0.025); mean modified (excluding the head, which was not treated) psoriasis area and severity index score was significantly different between Cal/BD aerosol foam and Cal/BD ointment (mean difference -0.6; p = 0.005). Rapid, continuous itch relief occurred with both active treatments. One adverse drug reaction was reported with Cal/BD aerosol foam (application site itch).

Conclusions: Cal/BD aerosol foam demonstrates significantly greater efficacy and similar tolerability compared with Cal/BD ointment for psoriasis treatment.

Keywords: Aerosol foam; betamethasone dipropionate; calcipotriene; psoriasis vulgaris; topical treatments.

Publication types

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

MeSH terms

  • Adult
  • Aerosols
  • Betamethasone / administration & dosage
  • Betamethasone / analogs & derivatives*
  • Calcitriol / administration & dosage
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Dermatologic Agents / administration & dosage*
  • Dermatologic Agents / therapeutic use
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Ointments
  • Psoriasis / drug therapy*
  • Single-Blind Method
  • Treatment Outcome


  • Aerosols
  • Dermatologic Agents
  • Drug Combinations
  • Ointments
  • calcipotriene
  • betamethasone-17,21-dipropionate
  • Betamethasone
  • Calcitriol