title: A Novel Aerosol Foam Formulation of Calcipotriol and Betamethasone Has No Impact on HPA Axis and Calcium Homeostasis in Patients With Extensive Psoriasis Vulgaris.
abstract: BACKGROUND
  Fixed combination calcipotriol 50 µg/g (Cal; as hydrate) plus betamethasone 0.5 mg/g (as dipropionate; BD) has been formulated in an innovative aerosol foam.
  
  
  OBJECTIVE
  To assess systemic safety of Cal/BD aerosol foam.
  
  
  METHODS
  In a multicentre, single-arm, open-label, maximal-use systemic-exposure trial, adult patients with moderate to severe, extensive psoriasis (15%-30% of body surface area, including ≥30% of scalp) applied Cal/BD foam once daily. Endpoints were week 4 abnormal adrenocorticotropic hormone (ACTH) challenge test and change in albumin-corrected serum calcium, 24-hour urinary calcium excretion, and urinary calcium-creatinine ratio.
  
  
  RESULTS
  35 patients reaching week 4 exhibited normal ACTH responses. At week 4, changes in calcium homeostasis were minor and not clinically relevant; no patients experienced elevations above normal. Disease severity generally improved, and 49% of patients achieved treatment success according to the Physician's Global Assessment of Disease Severity.
  
  
  CONCLUSIONS
  No clinically relevant HPA axis or calcium homeostasis impact was observed with 4 weeks of once-daily Cal/BD foam in patients with extensive psoriasis vulgaris.
authors.affiliation: The Derm Centre, Winnipeg, MB, Canada vhblackwood@shaw.ca.
authors.forename: Victoria
authors.initials: V
authors.lastname: Taraska
authors.affiliation: Oshawa Clinic, Oshawa, ON, Canada.
authors.forename: Raj
authors.initials: R
authors.lastname: Tuppal
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Martin
authors.initials: M
authors.lastname: Olesen
authors.affiliation: LEO Pharma A/S, Ballerup, Denmark.
authors.forename: Claus
authors.initials: C
authors.lastname: Bang Pedersen
authors.affiliation: K Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.
authors.forename: Kim
authors.initials: K
authors.lastname: Papp
mesh_terms: D000336:Aerosols; D001623:Betamethasone / Q000008:administration & dosage*; D002117:Calcitriol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002118:Calcium / Q000378:metabolism*; D003879:Dermatologic Agents / Q000008:administration & dosage*; D004338:Drug Combinations; D005260:Female; D006706:Homeostasis; D006801:Humans; D007030:Hypothalamo-Hypophyseal System / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010913:Pituitary-Adrenal System / Q000187:drug effects; D011565:Psoriasis / Q000188:drug therapy* / Q000503:physiopathology
chemical_list: D000336:Aerosols; D003879:Dermatologic Agents; D004338:Drug Combinations; C055085:calcipotriene; D001623:Betamethasone; D002117:Calcitriol; D002118:Calcium
keywords: dermatology; psoriasis