title: Effect of calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamic-pituitary-adrenal axis and calcium homeostasis in subjects with extensive psoriasis vulgaris: an open, non-controlled, 8-week trial.
abstract: BACKGROUND
  The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate is effective and safe in the treatment of psoriasis on the body and scalp within the general psoriasis patient population.
  
  
  OBJECTIVE
  To evaluate the systemic effects of once-daily use of two-compound topical suspension/gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium homeostasis in subjects with extensive psoriasis vulgaris.
  
  
  METHODS
  An open-label, single-group, 8-week trial in 43 subjects with extensive psoriasis covering 15-30% of the body surface area. Blood and 24-hour urine samples were collected and a standard-dose adrenocorticotropic hormone (ACTH) stimulation test was performed at baseline, weeks 4 and 8. Primary endpoints were serum cortisol 30 minutes after ACTH injection (HPA axis response abnormal at serum cortisol ≤18 μg/dL) and changes from baseline in albumin-corrected serum calcium (sCa), 24-hour urinary calcium excretion (24hCa) and urine calcium:creatinine ratio (Ca:Crea).
  
  
  RESULTS
  Two (4.7%) subjects showed signs of adrenal suppression based on the ACTH stimulation test results at week 4; both were withdrawn from treatment and had normal serum cortisol 30-minute values at follow-up 4 weeks later. None of the subjects who continued treatment to week 8 showed signs of adrenal suppression. There were no clinically relevant mean changes from baseline to weeks 4 and 8 in sCa, 24hCa or Ca:Crea and no subject had sCa above the reference range.
  
  
  CONCLUSIONS
  The two-compound topical suspension/gel containing calcipotriene plus betamethasone dipropionate may be applied once daily to extensive psoriasis vulgaris without generally causing adrenal suppression or disturbance of calcium homeostasis, consistent with previous findings. In a small number of patients with extensive psoriasis treated with large volumes of topical suspension, adrenal suppression may be observed. In the real-world setting, it is anticipated that systemic side-effects would occur in only a few cases within the general psoriasis patient population. ClinicalTrials.gov Identifier:
authors.forename: Shane
authors.initials: S
authors.lastname: Silver
authors.forename: Raj
authors.initials: R
authors.lastname: Tuppal
authors.forename: Aditya K
authors.initials: AK
authors.lastname: Gupta
authors.forename: Fabrice
authors.initials: F
authors.lastname: Clonier
authors.forename: Martin
authors.initials: M
authors.lastname: Olesen
authors.forename: Randy
authors.initials: R
authors.lastname: Leeder
authors.forename: Victoria
authors.initials: V
authors.lastname: Taraska
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; 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; D002118:Calcium / Q000378:metabolism; D003404:Creatinine / Q000652:urine; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; 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* / Q000473:pathology; D012720:Severity of Illness Index; D013535:Suspensions; D013997:Time Factors
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; D013535:Suspensions; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D003404:Creatinine; D002117:Calcitriol; D002118:Calcium