title: Efficacy and Safety of Calcipotriene Plus Betamethasone Dipropionate Aerosol Foam in Patients With Psoriasis Vulgaris--a Randomized Phase III Study (PSO-FAST).
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  proportion of patients at week 4 who achieved treatment success according to physician's global assessment.
  
  
  RESULTS
  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.
authors.forename: Craig
authors.initials: C
authors.lastname: Leonardi
authors.forename: Jerry
authors.initials: J
authors.lastname: Bagel
authors.forename: Paul
authors.initials: P
authors.lastname: Yamauchi
authors.forename: David
authors.initials: D
authors.lastname: Pariser
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xu
authors.forename: Martin
authors.initials: M
authors.lastname: Olesen
authors.forename: Marie Louise
authors.initials: ML
authors.lastname: Østerdal
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
mesh_terms: D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D000369:Aged, 80 and over; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012867:Skin / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D004338:Drug Combinations; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol