title: Comparative study of calcipotriene (MC 903) ointment and fluocinonide ointment in the treatment of psoriasis.
abstract: BACKGROUND
  The topical vitamin D analogue calcipotriene has been reported to be an effective treatment for patients with psoriasis. Comparative studies with topical steroids are informative in judging this new therapy.
  
  
  OBJECTIVE
  The purpose of this study was to evaluate the efficacy and safety of calcipotriene ointment 0.005% versus fluocinonide ointment 0.05% in the treatment of plaque psoriasis.
  
  
  METHODS
  This study was a randomized, double-blind, parallel-group, active-controlled trial in adults who had at least mild overall disease severity and plaque elevation of at least moderate severity. Treatments were applied twice daily for 6 weeks, and subjects were evaluated at weeks 0, 2, 4, and 6. Subjects were graded on a 9-point scale (0 to 8) for scaling, erythema, plaque elevation, and for overall disease severity. A physician's global assessment of improvement/worsening was performed at every visit.
  
  
  RESULTS
  A total of 114 subjects were enrolled at six study sites. Ninety-nine subjects completed the trial. Mean scores for signs of scaling and plaque elevation in calcipotriene-treated subjects were significantly lower by week 2 than in the fluocinonide-treated subjects. These scores continued to be significantly lower than fluocinonide through week 6 (p < 0.05). Mean scores for erythema in calcipotriene-treated subjects were significantly lower than those in fluocinonide-treated subjects at weeks 4 and 6 (p < 0.05). Both the physician's global assessment and overall disease severity showed statistically significant treatment differences in favor of calcipotriene at week 4 (p < 0.05). This superior efficacy continued through week 6. Treatment-related adverse events were observed in 12 calcipotriene-treated subjects and 5 fluocinonide-treated subjects; all were considered minor.
  
  
  CONCLUSIONS
  Calcipotriene was superior to fluocinonide in the treatment of plaque psoriasis.
authors.affiliation: Department of Dermatology, Baylor College of Medicine, Houston, TX 77030.
authors.forename: S
authors.initials: S
authors.lastname: Bruce
authors.forename: W W
authors.initials: WW
authors.lastname: Epinette
authors.forename: T
authors.initials: T
authors.lastname: Funicella
authors.forename: A
authors.initials: A
authors.lastname: Ison
authors.forename: E L
authors.initials: EL
authors.lastname: Jones
authors.forename: R
authors.initials: R
authors.lastname: Loss
authors.forename: M E
authors.initials: ME
authors.lastname: McPhee
authors.forename: C
authors.initials: C
authors.lastname: Whitmore
mesh_terms: D000328:Adult; D000368:Aged; 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*; D004311:Double-Blind Method; D005260:Female; D005447:Fluocinonide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012449:Safety; D013997:Time Factors
chemical_list: D003879:Dermatologic Agents; D009824:Ointments; C055085:calcipotriene; D005447:Fluocinonide; D002117:Calcitriol