title: Safety and efficacy of combined high-dose treatment with calcipotriol ointment and solution in patients with psoriasis.
abstract: BACKGROUND
  In the vast majority of psoriatic patients, psoriatic lesions are localised on the body as well as on the scalp. Therefore, safety data on the combined use of calcipotriol in lotion and calcipotriol in ointment are needed.
  
  
  OBJECTIVE
  This study investigated the effect of high-dose treatment with a combination of calcipotriol ointment and scalp solution on calcium metabolism, indices of bone turnover and PASI in patients with extensive psoriasis.
  
  
  METHODS
  Following a 2-week wash-out period, 88 patients were randomised to 4 weeks of treatment with either calcipotriol ointment/scalp solution (80-100 g/week and 30-50 ml/week, respectively; n = 41) or with a dithranol/tar regimen (n = 47). Patients were seen at weeks 1, 2 and 4 during treatment and 1 week following cessation of treatment.
  
  
  RESULTS
  No significant differences at the end of treatment were found between the 2 groups with respect to 24-hour urinary excretion of calcium (expressed as calcium/creatinine ratio), phosphate or pyridinoline, serum concentrations of calcium (albumin corrected), creatinine, phosphate, parathyroid hormone, 25-hydroxyvitamin D(3), 1,25-dihydroxyvitamin D(3), osteocalcin, alkaline phosphatase (total and bone-specific iso-enzymes) or 1-collagen telopeptide. At the end of treatment, the psoriasis area and severity index had decreased by 57.4% in the calcipotriol group and by 36.1% in the dithranol/tar group (p = 0.004). Investigators' and patients' assessments of overall efficacy also favoured treatment with calcipotriol (p < 0.001).
  
  
  CONCLUSIONS
  The combined use of calcipotriol ointment/scalp solution did not affect the indices of calcium metabolism or bone turnover and was significantly more effective than dithranol/tar in reducing disease severity and extent in patients with extensive psoriasis.
authors.affiliation: Academisch Ziekenhuis Nijmegen, The Netherlands. p.vandekerkhof@derma.azn
authors.forename: P C M
authors.initials: PC
authors.lastname: Van de Kerkhof
authors.forename: C
authors.initials: C
authors.lastname: Green
authors.forename: K J
authors.initials: KJ
authors.lastname: Hamberg
authors.forename: P E
authors.initials: PE
authors.lastname: Hutchinson
authors.forename: J K
authors.initials: JK
authors.lastname: Jensen
authors.forename: P
authors.initials: P
authors.lastname: Kidson
authors.forename: K
authors.initials: K
authors.lastname: Kragballe
authors.forename: F G
authors.initials: FG
authors.lastname: Larsen
authors.forename: C S
authors.initials: CS
authors.lastname: Munro
authors.forename: D M
authors.initials: DM
authors.lastname: Tillman
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000875:Anthralin / Q000008:administration & dosage*; D002117:Calcitriol / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011336:Probability; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D012996:Solutions; D016896:Treatment Outcome
chemical_list: D009824:Ointments; D012996:Solutions; C055085:calcipotriene; D002117:Calcitriol; D000875:Anthralin