Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST)

J Drugs Dermatol. 2015 Dec;14(12):1468-77.


Introduction: An innovative aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) designed to improve treatment outcomes.

Objective: To compare the efficacy and safety of Cal/BD aerosol foam with aerosol foam vehicle in patients with psoriasis.

Design: Phase III, double-blind, randomized PSO-FAST (Cal/BD foam in PSOriasis vulgaris, a Four-week, vehicle-controlled, efficacy And Safety Trial) study recruited patients with ≥ mild severity psoriasis of the trunk and/or limbs from 27 US outpatient sites (NCT01866163). Patients were randomized (3:1) to Cal/BD foam or vehicle once-daily for 4 weeks.

Primary outcome: proportion of patients at week 4 who achieved treatment success according to physician's global assessment.

Secondary outcomes: modified (excluding head) psoriasis area and severity index (mPASI) and patient's assessment of itch (visual analog scale). Safety was monitored by adverse events/calcium homeostasis.

Results: 426 patients enrolled between June and October 2013 (Cal/BD foam, n=323; vehicle, n=103). At week 4, significantly more patients using Cal/BD foam achieved treatment success versus vehicle (53.3 versus 4.8%; OR 30.3, 95% CI 9.7,94.3; P < .001) and mean mPASI score was significantly lower for patients using Cal/BD foam than vehicle (2.0 versus 5.5; adjusted difference -3.3, P <.001). Significantly greater itch relief was observed for patients using Cal/BD foam than vehicle (P = .010 at day 3, P < .001 from day 5). Adverse drug reactions were reported in 10 Cal/BD foam patients (3.1%) and two vehicle patients (1.9%); events occurred in one patient each except application site pain (Cal/BD foam, two patients; vehicle, one patient). There were no clinically significant changes in calcium homeostasis.

Conclusions: Cal/BD foam was efficacious, achieved rapid itch relief and was well tolerated in patients with body psoriasis. This innovative aerosol foam formulation is expected to become a valuable treatment option.

Publication types

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

MeSH terms

  • Adolescent
  • Adult
  • Aerosols
  • Aged
  • Aged, 80 and over
  • Betamethasone / administration & dosage
  • Betamethasone / adverse effects
  • Betamethasone / analogs & derivatives*
  • Betamethasone / therapeutic use
  • Calcitriol / administration & dosage
  • Calcitriol / adverse effects
  • Calcitriol / analogs & derivatives*
  • Calcitriol / therapeutic use
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects
  • Dermatologic Agents / therapeutic use*
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Psoriasis / drug therapy*
  • Psoriasis / pathology
  • Skin / pathology
  • Treatment Outcome
  • Young Adult


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

Associated data

  • ClinicalTrials.gov/NCT01866163