title: DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis.
abstract: BACKGROUND
  A novel 0.05% betamethasone dipropionate emollient spray (DFD-01) was formulated to optimize penetration of steroid to the epidermal layers affected by psoriasis.
  
  
  OBJECTIVE
  To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05% lotion (Diprolene) for the topical treatment of moderate plaque psoriasis.
  
  
  METHODS
  Adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10-20% BSA) were randomized 2:1:1 to DFD-01, Diprolene, or Vehicle. Products were applied twice daily to affected areas for 14 days. Treatment success was defined as IGA=0 or 1 and ≥ 2-grade improvement from baseline. IGA and target lesion Total Sign Score (TSS; sum of erythema, scaling, and plaque elevation scores) were assessed at baseline and at days 4, 8, and 15. Adverse events (AEs) were recorded.
  
  
  RESULTS
  351 subjects with moderate psoriasis were randomized to DFD-01 (n=174), Diprolene (n=90), or Vehicle (n=87). Mean BSA was 13-14%. Treatment success was achieved in 19.0% DFD-01, 18.9% Diprolene, and 2.3% Vehicle (P<0.001 DFD-01 vs Vehicle) at day 15. Treatment success at day 8 was 10% DFD-01, 6.7% Diprolene, and 1.2% Vehicle (P=0.003 DFD-01 vs Vehicle). TSS was significantly reduced with DFD-01 compared with Vehicle at days 4, 8, and 15 (P ≤ 0.006) and compared with Diprolene at day 4 (P=0.010). DFD-01 relieved signs of erythema and scaling earlier than Diprolene or Vehicle, showing significant improvements on day 4 (P ≤ 0.048). All products were well tolerated. Significantly more burning/stinging was reported with Diprolene than DFD-01 (13.6% vs 4.1%, P=0.006).
  
  
  CONCLUSIONS
  Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis. DFD-01 demonstrated similar efficacy to super potent Diprolene lotion. Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects. DFD-01 was well tolerated and had an excellent safety profile.
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Fowler
authors.forename: Adelaide A
authors.initials: AA
authors.lastname: Hebert
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004311:Double-Blind Method; D016503:Drug Delivery Systems / Q000379:methods*; D004643:Emollients / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D004643:Emollients; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone