title: Superior efficacy of calcipotriene and betamethasone dipropionate aerosol foam versus ointment in patients with psoriasis vulgaris--A randomized phase II study.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: a Department of Dermatology , University of California , San Francisco , San Francisco , CA , USA .
authors.forename: John
authors.initials: J
authors.lastname: Koo
authors.affiliation: b Department of Dermatology , University of Texas Health Science Center , Houston , TX , USA .
authors.forename: Stephen
authors.initials: S
authors.lastname: Tyring
authors.affiliation: c University of Washington School of Medicine , Seattle , WA , USA .
authors.forename: William P
authors.initials: WP
authors.lastname: Werschler
authors.affiliation: d Suzanne Bruce and Associates, PA , Houston , TX , USA .
authors.forename: Suzanne
authors.initials: S
authors.lastname: Bruce
authors.affiliation: e LEO Pharma A/S , Ballerup , Denmark , and.
authors.forename: Martin
authors.initials: M
authors.lastname: Olesen
authors.affiliation: e LEO Pharma A/S , Ballerup , Denmark , and.
authors.forename: John
authors.initials: J
authors.lastname: Villumsen
authors.affiliation: f Psoriasis Treatment Center of Central New Jersey , East Windsor , NJ , USA.
authors.forename: Jerry
authors.initials: J
authors.lastname: Bagel
mesh_terms: D000328:Adult; D000336:Aerosols; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D004338:Drug Combinations; D009824:Ointments; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol
keywords: Aerosol foam; betamethasone dipropionate; calcipotriene; psoriasis vulgaris; topical treatments