title: A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial.
abstract: BACKGROUND
  There is a need for new treatments for scalp psoriasis, as many topical treatments are cosmetically unacceptable and difficult to apply, resulting in poor compliance.
  
  
  OBJECTIVE
  To compare the efficacy and safety of a new, once-daily, two-compound scalp formulation (Xamiol; LEO Pharma A/S, Ballerup, Denmark) containing calcipotriol 50 microg g(-1) plus betamethasone 0.5 mg g(-1) (as dipropionate), with the active ingredients as single compounds in the same vehicle.
  
  
  METHODS
  This 8-week, multicentre, double-blind, parallel-group study, randomized adult patients with scalp psoriasis involving > 10% of the scalp to the two-compound scalp formulation (n = 568), betamethasone dipropionate 0.5 mg g(-1) (n = 563), or calcipotriol 50 microg g(-1) (n = 286). The primary efficacy measure was the proportion of patients with 'absence of disease' or 'very mild disease' according to investigators' assessments at week 8.
  
  
  RESULTS
  The proportion of patients with 'absence of disease' or 'very mild disease' at week 8 was significantly higher in the two-compound group (68.4%) than the betamethasone dipropionate (61.0%, P = 0.0079) or calcipotriol (43.4%, P < 0.0001) groups. The proportion of patients rating their scalp psoriasis as 'clear' or 'almost clear' was significantly higher for the two-compound scalp formulation (69.6%) than for betamethasone dipropionate (59.9%, P = 0.0006) or calcipotriol (44.7%, P < 0.0001). The incidence of lesional/perilesional adverse events was lower in the two-compound and betamethasone dipropionate groups than the calcipotriol group.
  
  
  CONCLUSIONS
  The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.
authors.affiliation: Department of Dermatology, University Hospital Nijmegen, Centrum St Radboud, Postbus 9101, 6525 GL Nijmegen, The Netherlands.
authors.forename: P C M
authors.initials: PC
authors.lastname: van de Kerkhof
authors.forename: V
authors.initials: V
authors.lastname: Hoffmann
authors.forename: A
authors.initials: A
authors.lastname: Anstey
authors.forename: L
authors.initials: L
authors.lastname: Barnes
authors.forename: C
authors.initials: C
authors.lastname: Bolduc
authors.forename: K
authors.initials: K
authors.lastname: Reich
authors.forename: S
authors.initials: S
authors.lastname: Saari
authors.forename: S
authors.initials: S
authors.lastname: Segaert
authors.forename: L
authors.initials: L
authors.lastname: Vaillant
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001623:Betamethasone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol