title: Efficacy and Safety of Calcipotriol Plus Betamethasone Dipropionate Aerosol Foam Compared with Betamethasone 17-Valerate-Medicated Plaster for the Treatment of Psoriasis.
abstract: Fixed combination calcipotriol as hydrate (Cal) 50 µg/g plus betamethasone as dipropionate (BD) 0.5 mg/g aerosol foam is an alcohol-free treatment for psoriasis. Betamethasone 17-valerate 2.25 mg (BV)-medicated plasters are recommended for treating psoriasis plaques localized in difficult-to-treat (DTT; elbow, knee, anterior face of the tibia) areas.
  
  
  
  The aim of this study was to compare the efficacy of Cal/BD foam with BV-medicated plaster in patients with plaque psoriasis.
  
  
  
  In this phase IIa, randomized, single-center, investigator-blinded, 4-week study, both Cal/BD foam and BV-medicated plaster were applied once daily to six test sites (three for each treatment). The primary efficacy endpoint was absolute change in total clinical score (TCS; sum of erythema, scaling, and infiltration); secondary endpoints were changes from baseline in each individual clinical score, ultrasonographic changes (total skin and echo-poor band thickness), and safety; and post hoc analysis was change from baseline in TCS on DTT areas.
  
  
  
  Thirty-five patients were included. Least-squares mean change in TCS from baseline was significantly greater for Cal/BD foam (-5.8) than BV-medicated plaster (-3.7; difference -2.2; 95% confidence interval -2.6 to -1.8; p < 0.001); greater changes for Cal/BD foam were observed from day 8 for each clinical sign. Absolute total skin and echo-poor band thickness change was significantly greater for Cal/BD foam than for BV-medicated plaster (both p < 0.001). Post hoc analyses showed that Cal/BD foam was significantly more effective than BV-medicated plaster on DTT areas after 4 weeks (p < 0.001), and both treatments were well tolerated.
  
  
  
  Cal/BD foam demonstrated superior efficacy versus BV-medicated plasters, including on DTT areas, in patients with plaque psoriasis.
  
  
  
  NCT02518048.
authors.affiliation: Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L'Archet 2, 06202, Nice Cedex 3, France. catherine.queille-roussel@skinpharma.fr.
authors.forename: Catherine
authors.initials: C
authors.lastname: Queille-Roussel
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Monika
authors.initials: M
authors.lastname: Rosen
authors.affiliation: LEO Pharma (Laboratoires LEO), Voisins Le Bretonneux, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Clonier
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Kasper
authors.initials: K
authors.lastname: Nørremark
authors.affiliation: Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Hôpital L'Archet 2, 06202, Nice Cedex 3, France.|Service de Dermatologie, University Hospital of Nice, Nice, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Lacour
mesh_terms: D000328:Adult; D000336:Aerosols / Q000627:therapeutic use; D001623:Betamethasone / Q000008:administration & dosage / Q000031:analogs & derivatives*; D001624:Betamethasone Valerate / Q000008:administration & dosage*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003879:Dermatologic Agents / Q000008:administration & dosage; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy*; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D005938:Glucocorticoids; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D001624:Betamethasone Valerate; D002117:Calcitriol