title: Aerosol Foam Formulation of Fixed Combination Calcipotriene Plus Betamethasone Dipropionate is Highly Efficacious in Patients With Psoriasis Vulgaris: Pooled Data From Three Randomized Controlled Studies.
abstract: BACKGROUND
  Calcipotriene 0.005% (Cal)/betamethasone dipropionate 0.064% (BD) aerosol foam was developed as a new treatment option for patients with psoriasis. This pooled analysis evaluated the efficacy of this formulation for 4 weeks of treatment.<BR />
  
  
  METHODS
  Patients aged &ge;18 years with mild-severe psoriasis were enrolled into three Phase II/III studies (nCT01536886, nCT01536938, nCT01866163); each study evaluated Cal/BD aerosol foam versus different comparators. Endpoints included: proportion of patients clear/almost clear with &ge;2-step improvement in physician's global assessment of disease severity ('treatment success'); modified (excluding head) psoriasis area and severity index (mPASI); proportion of patients with &ge;75% reduction in mPASI (PASI75); change in itch (according to visual analog scale [VAS]).<BR />
  
  
  RESULTS
  1104 patients were included in the pooled analysis: Cal/BD aerosol foam (n=564), Cal/BD ointment (n=135), BD aerosol foam (n=101), Cal aerosol foam (n=101), aerosol foam vehicle (n=152), ointment vehicle (n=51). At week 4, 51% of Cal/BD aerosol foam patients achieved treatment success, a higher proportion than in all other groups (Cal/BD ointment, 43%; BD aerosol foam, 31%; Cal aerosol foam, 15%; aerosol foam vehicle, 5%; ointment vehicle, 8%). Greater percentage mean decrease in mPASI with Cal/BD aerosol foam was noted versus other treatments at week 4 (72% vs 63%, 53%, 43%, 32%, and 33%, respectively); week 4 PASI75 rate was also greater (51% vs 41%, 34%, 18%, 7%, and 10%, respectively). Cal/BD aerosol foam was efficacious irrespective of baseline disease severity and on all body areas assessed (arms, legs, trunk). Cal/BD aerosol foam alleviated itch as early as week 1 (change in itch VAS: -30 mm), maintained to week 4 (change in itch VAS: -41 mm).<BR />
  
  
  CONCLUSIONS
  Cal/BD aerosol foam was significantly more effective than Cal/BD ointment and the individual active ingredients for treating psoriasis vulgaris, resulting in greater and faster reduction in disease severity and rapid, effective relief of itch.<BR /><BR /> <em>J Drugs Dermatol</em>. 2016;15(8):951-957.
authors.forename: Linda
authors.initials: L
authors.lastname: Stein Gold
authors.forename: Mark
authors.initials: M
authors.lastname: Lebwohl
authors.forename: Alan
authors.initials: A
authors.lastname: Menter
authors.forename: John
authors.initials: J
authors.lastname: Villumsen
authors.forename: Monika
authors.initials: M
authors.lastname: Rosen
authors.forename: John
authors.initials: J
authors.lastname: Koo
mesh_terms: D000293:Adolescent; D000328:Adult; D000336:Aerosols; D000368:Aged; D000369:Aged, 80 and over; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000737:chemistry; D004338:Drug Combinations; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000175:diagnosis* / Q000188:drug therapy*; D013223:Statistics as Topic; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000336:Aerosols; D004338:Drug Combinations; D009824:Ointments; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol