title: Improvement in Extensive Moderate Plaque Psoriasis With a Novel Emollient Spray Formulation of Betamethasone Dipropionate 0.05.
abstract: BACKGROUND
  A novel formulation of 0.05% betamethasone dipropionate in an emollient spray vehicle (DFD-01) was developed to deliver steroid to the skin layers most affected by psoriasis.
  
  
  OBJECTIVE
  To compare the efficacy and safety of DFD-01 to its vehicle for the treatment of moderate plaque psoriasis over 4 weeks.
  
  
  METHODS
  Two Phase 3 trials enrolled adults with moderate psoriasis (Investigator Global Assessment [IGA]=3; 10-20% body surface area [BSA]) and randomized them 2:1 to DFD-01 or Vehicle. Products were applied twice daily to affected areas for 28 days. Treatment success was defined as an IGA=0 or 1 and ≥ 2-grade improvement from baseline. Primary endpoint was the proportion of subjects achieving treatment success at day 15.
  
  
  RESULTS
  Moderate psoriasis subjects were enrolled in Study 1 (174 DFD-01; 87 Vehicle) and Study 2 (182 DFD-01; 95 Vehicle). Mean BSA was 13-14%. Treatment success was achieved in significantly more subjects using DFD-01 than Vehicle at day 15 in both Study 1 (P<0.001) and Study 2 (P=0.002), and at day 29 (both studies P<0.001). Treatment success with DFD-01 was significant at day 8 in Study 1 (P=0.003) but not in Study 2 (P=0.156). Erythema, scaling, and plaque elevation scores of target lesions were significantly reduced as early as day 4 with DFD-01. Adverse events were similar between groups, with no increase between 2 and 4 weeks.
  
  
  CONCLUSIONS
  These studies demonstrate DFD-01's excellent efficacy and safety for the treatment of extensive psoriasis (10-20% BSA). DFD-01 achieved treatment success in significantly more subjects than Vehicle after 2 and 4 weeks of treatment, and showed early onset of action with improved signs of erythema, scaling and elevation of target lesions after 4 days of treatment. This medium potency formulation provides a safe and effective choice for topical steroid treatment of psoriasis.
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
authors.forename: J Mark
authors.initials: JM
authors.lastname: Jackson
authors.forename: Melissa L F
authors.initials: ML
authors.lastname: Knuckles
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Weiss
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000737:chemistry; D001830:Body Surface Area; D004311:Double-Blind Method; D004643:Emollients / Q000008:administration & dosage* / Q000737:chemistry; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D014677:Pharmaceutical Vehicles / Q000008:administration & dosage / Q000737:chemistry; D011565:Psoriasis / Q000188:drug therapy*; D012867:Skin / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004643:Emollients; D005938:Glucocorticoids; D014677:Pharmaceutical Vehicles; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone