title: Efficacy of an innovative aerosol foam formulation of fixed combination calcipotriol plus betamethasone dipropionate in patients with psoriasis vulgaris.
abstract: OBJECTIVE
  The antipsoriatic effect of an innovative aerosol foam formulation of fixed combination calcipotriol 50 μg/g (as hydrate; Cal) and betamethasone 0.5 mg/g (as dipropionate; BD) was explored in order to compare the effect with that of the first-line treatment Cal/BD ointment.
  
  
  METHODS
  This was a Phase IIa, single-centre, investigator-blinded, exploratory study, with intra-individual comparison using a modified psoriasis plaque test. Patients were treated once daily (6 days/week) for 4 weeks with Cal/BD foam, Cal/BD ointment, BD foam and Cal/BD foam vehicle, randomized to four plaque test sites (5 cm(2) each). The primary efficacy endpoint was change in total clinical score (TCS; sum of erythema, scaling and lesional thickness). Secondary endpoints included ultrasonographic changes in total skin thickness and echo-poor band thickness, and adverse events.
  
  
  RESULTS
  Twenty-four patients, median age 52.5 years (range 21-75), completed this study. At week 4, test sites treated with Cal/BD foam had a significantly greater decrease in mean (±SD) TCS (-6.00 ± 1.27) versus those treated with Cal/BD ointment (-5.25 ± 1.78; difference -0.75; 95 % CI -1.46 to -0.04; p = 0.038), BD foam (-4.96 ± 1.85; difference -1.04; 95 % CI -1.75 to -0.33; p = 0.005) or foam vehicle (-1.88 ± 1.12; difference -4.13; 95 % CI -4.83 to -3.42; p < 0.001). Total skin thickness and echo-poor band thickness of Cal/BD foam-treated sites were reduced to a greater extent than those treated with comparators. Eleven patients reported 17 adverse events, the most frequent being headache (five patients). There were no lesional/perilesional adverse events or adverse drug-related events.
  
  
  CONCLUSIONS
  Cal/BD foam demonstrated a significant improvement in antipsoriatic effect over Cal/BD ointment, BD foam and foam vehicle alone.
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.forename: Martin
authors.initials: M
authors.lastname: Olesen
authors.forename: John
authors.initials: J
authors.lastname: Villumsen
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Lacour
mesh_terms: D000328:Adult; D000336:Aerosols / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments / Q000008:administration & dosage / Q000627:therapeutic use; D011565:Psoriasis / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016037:Single-Blind Method; D014463:Ultrasonography; D055815:Young Adult
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D004338:Drug Combinations; D009824:Ointments; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol