title: Long-term use of a 4% sodium cromoglicate cutaneous emulsion in the treatment of moderate to severe atopic dermatitis in children.
abstract: BACKGROUND
  Sodium cromoglicate (SCG), a chromone with anti-inflammatory, anti-itch and anti-allergic properties. We report a long-term study of a 4% aqueous solution of SCG in children with moderate to severe atopic dermatitis (AD).
  
  
  METHODS
  Children aged 1 to 12 years with AD were entered into a 12-week randomised clinical trial (RCT), followed by 12 months open treatment with known 4% SCG emulsion (Altocrom®). Primary endpoint was change in SCORAD score. Secondary endpoints included symptom severity, Quality of Life, concomitant treatment usage, global assessments.
  
  
  RESULTS
  One hundred and seventy-seven subjects entered, 118 treated with 4% SCG emulsion and 59 with vehicle: 128 completed 12 months in open study. SCORAD score reduced during RCT by -15.3 (-33%) on 4% SCG emulsion and -18.0 (-39%) on vehicle: p = 0.2331. After 12 months reduction was 56%. No secondary endpoint showed differences between treatments during RCT. Thirty-two subjects reported treatment related events during RCT and open trial. Eleven (7%) reported application site discomfort. Most were reported as mild and most resolved without intervention and the study drug was stopped in one case only.
  
  
  CONCLUSIONS
  SCG 4% cutaneous emulsion was well tolerated in children treated for 15 months.
authors.affiliation: a The David Hide Asthma and Allergy Research Centre , St Mary's Hospital , Newport, Isle of Wight , UK .
authors.forename: Alan Martin
authors.initials: AM
authors.lastname: Edwards
authors.affiliation: a The David Hide Asthma and Allergy Research Centre , St Mary's Hospital , Newport, Isle of Wight , UK .
authors.forename: Dalia
authors.initials: D
authors.lastname: Bibawy
authors.affiliation: a The David Hide Asthma and Allergy Research Centre , St Mary's Hospital , Newport, Isle of Wight , UK .
authors.forename: Sharon
authors.initials: S
authors.lastname: Matthews
authors.affiliation: a The David Hide Asthma and Allergy Research Centre , St Mary's Hospital , Newport, Isle of Wight , UK .
authors.forename: Nicky
authors.initials: N
authors.lastname: Tongue
authors.affiliation: a The David Hide Asthma and Allergy Research Centre , St Mary's Hospital , Newport, Isle of Wight , UK .
authors.forename: Syed Hasan
authors.initials: SH
authors.lastname: Arshad
authors.affiliation: b Department of Paediatrics , Institute of Clinical Medicine, University of Oslo , Oslo , Norway .
authors.forename: Karin
authors.initials: K
authors.lastname: Lødrup Carlsen
authors.affiliation: c Pediatric Department , Stavanger University Hospital , Stavanger , Norway .
authors.forename: Knut
authors.initials: K
authors.lastname: Øymar
authors.affiliation: d Department of Paediatrics , Barnet and Chase Farm Hospitals NHS Trust, Barnet , Hertfordshire , UK .
authors.forename: Ian
authors.initials: I
authors.lastname: Pollock
authors.affiliation: e Children's Centre , Dorset County Hospital , Dorchester , UK .
authors.forename: Rollo
authors.initials: R
authors.lastname: Clifford
authors.affiliation: f Department of Dermatology , Cardiff University , Wales , UK , and.
authors.forename: Anne
authors.initials: A
authors.lastname: Thomas
authors.affiliation: f Department of Dermatology , Cardiff University , Wales , UK , and.
authors.forename: Rufaro
authors.initials: R
authors.lastname: Gamanya
authors.affiliation: f Department of Dermatology , Cardiff University , Wales , UK , and.
authors.forename: Jui
authors.initials: J
authors.lastname: Vyas
authors.affiliation: g Department of Statistics , EmStat Ltd . , Leicester , UK.
authors.forename: Michael T
authors.initials: MT
authors.lastname: Stevens
authors.affiliation: b Department of Paediatrics , Institute of Clinical Medicine, University of Oslo , Oslo , Norway .
authors.forename: Kai-Håkon
authors.initials: KH
authors.lastname: Carlsen
mesh_terms: D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D004205:Cromolyn Sodium / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D011537:Pruritus / Q000188:drug therapy; D011788:Quality of Life; D012720:Severity of Illness Index
chemical_list: D018926:Anti-Allergic Agents; D000893:Anti-Inflammatory Agents; D004205:Cromolyn Sodium
keywords: Children; clinical trial; cromolyn; eczema; long-term; topical