title: Safety and efficacy of calcipotriol plus betamethasone dipropionate gel in the treatment of scalp psoriasis in adolescents 12-17 years of age.
abstract: BACKGROUND
  Plaque psoriasis has a relatively high prevalence in adolescence, resulting in a significant impact on quality of life, including social interactions.
  
  
  OBJECTIVE
  The primary objective was to assess the safety of once-daily application of fixed-combination calcipotriol plus betamethasone dipropionate gel in adolescent scalp psoriasis. Assessment of efficacy was a secondary objective.
  
  
  METHODS
  This phase II, multicentre, single-arm, open-label, 8-week trial included patients aged 12-17 years with moderate-to-very severe scalp psoriasis according to Investigator's Global Assessment (IGA) (≥ 10% of the scalp area affected).
  
  
  RESULTS
  Seventy-eight patients received treatment. Twenty-seven patients (35%) reported a total of 64 adverse events (AEs); most were mild (33/64) or moderate (22/64) in severity and there were no serious AEs. No cases of hypercalcaemia were reported, and the mean changes from baseline to end of treatment in albumin-corrected serum calcium (0·00 mmol L(-1)), 24-h urinary calcium excretion (-0·03 mmol per 24 h) and urinary calcium-to-creatinine ratio (-0·12 mmol g(-1)) were not considered clinically relevant. At the end of treatment 66 patients (85%) were clear or almost clear according to IGA. There was an 80% improvement in mean Total Sign Score from baseline to end of treatment. In total, at the end of treatment, 87% of patients rated their scalp psoriasis as clear or very mild, and 75 (96%) had no or mild pruritus compared with 14 (18%) at baseline.
  
  
  CONCLUSIONS
  Once-daily calcipotriol plus betamethasone dipropionate gel is well tolerated and efficacious for scalp psoriasis in adolescents.
authors: SKiN Centre for Dermatology, 743 Lansdowne Street West, Peterborough, ON, Canada, K9J 1Z.
authors: M
authors: M
authors: Gooderham
authors: J-M
authors: JM
authors: Debarre
authors: J
authors: J
authors: Keddy-Grant
authors: Z
authors: Z
authors: Xu
authors: M
authors: M
authors: Kurvits
authors: M
authors: M
authors: Goodfield
mesh_terms: D000279:Administration, Cutaneous; D000293:Adolescent; D001623:Betamethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D011565:Psoriasis / Q000188:drug therapy*; D012536:Scalp Dermatoses / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D004338:Drug Combinations; D005782:Gels; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol