title: A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp.
abstract: BACKGROUND
  Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.
  
  
  METHODS
  Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.<BR>
  
  
  RESULTS
  At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P <.001); a significant difference between groups was also observed at weeks 2 (P = .041) and 4 (P <.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P = .544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P = .019) and plaque thickness (P =.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema.
  
  
  CONCLUSIONS
  An 8-week study provides limited safety and efficacy data.<BR>
  
  
  CONCLUSIONS
  Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.
authors.affiliation: Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA. sfeldman@wakehealth.edu
authors.forename: Steven R
authors.initials: SR
authors.lastname: Feldman
authors.forename: Mary
authors.initials: M
authors.lastname: Mills
authors.forename: Thomas
authors.initials: T
authors.lastname: Brundage
authors.forename: William J
authors.initials: WJ
authors.lastname: Eastman
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004890:Erythema / Q000188:drug therapy / Q000209:etiology; 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: D003879:Dermatologic Agents; C055085:calcipotriene; D002117:Calcitriol