title: A new scalp formulation of calcipotriene plus betamethasone compared with its active ingredients and the vehicle in the treatment of scalp psoriasis: a randomized, double-blind, controlled trial.
abstract: BACKGROUND
  New topical treatments in scalp psoriasis are needed because many current topical treatments are disliked by patients and associated with poor compliance.
  
  
  OBJECTIVE
  To compare the efficacy and safety of once-daily, two-compound scalp formulation containing calcipotriene plus betamethasone dipropionate with the individual components in the same vehicle and the vehicle alone.
  
  
  METHODS
  In this 8-week, multicenter, randomized, double-blind study, patients with scalp psoriasis were randomized to treatment with the two-compound scalp formulation (calcipotriene 50 microg/g plus betamethasone 0.5 mg/g, as dipropionate) (n = 541), betamethasone 0.5 mg/g (as dipropionate) in the same vehicle (n = 556), calcipotriene 50 microg/g in the same vehicle (n = 272), or vehicle alone (n = 136).
  
  
  RESULTS
  More patients achieved "absent" or "very mild" disease at week 8 with the two-compound scalp formulation (71.2%) compared with betamethasone dipropionate in the same vehicle (64.0%, p = .011), calcipotriene in the same vehicle (36.8%, p < .0001), or the vehicle (22.8%, p < .0001).
  
  
  CONCLUSIONS
  Efficacy of the active comparators in the study has not been established in relation to calcipotriene and betamethasone formulations available for clinical use.
  
  
  CONCLUSIONS
  Calcipotriene plus betamethasone dipropionate scalp formulation was more effective than either of the individual components or the vehicle alone.
authors.affiliation: Department of Dermatology, Health Sciences Faculty University of Copenhagen, Roskilde Hospital, Roskilde, Denmark. gbj@regionsjaelland.dk
authors.forename: Gregor B E
authors.initials: GB
authors.lastname: Jemec
authors.forename: Cecilia
authors.initials: C
authors.lastname: Ganslandt
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Ortonne
authors.forename: Yves
authors.initials: Y
authors.lastname: Poulin
authors.forename: A David
authors.initials: AD
authors.lastname: Burden
authors.forename: Pablo
authors.initials: P
authors.lastname: de Unamuno
authors.forename: Berit
authors.initials: B
authors.lastname: Berne
authors.forename: Américo
authors.initials: A
authors.lastname: Figueiredo
authors.forename: Joar
authors.initials: J
authors.lastname: Austad
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012536:Scalp Dermatoses / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D012867:Skin / Q000473:pathology; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D014677:Pharmaceutical Vehicles; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol