title: A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children.
abstract: BACKGROUND
  Atopic dermatitis (AD) is a chronic inflammatory skin disease. Sodium cromoglicate (SCG) is a chromone with anti-inflammatory, anti-itch and anti-allergic activity. This trial is a 12-week comparison (RCT) of a 4% SCG cutaneous emulsion with its vehicle in AD.
  
  
  METHODS
  208 children aged 2-12 years participated, 104 in each group. The primary endpoint was change in SCORAD score. Secondary endpoints included SASSAD score, topical steroid usage and global assessments.
  
  
  RESULTS
  SCORAD was reduced by 28% (SCG group) and by 19% (vehicle): difference was statistically significant (p = 0.03) after 8 weeks and nearly significant (p = 0.09) after 12. A similar result occurred in SASSAD (p = 0.001 at 8 weeks). In subjects without major protocol deviations (SCG-64, vehicle-63), difference in SCORAD remained significant at 12 weeks (p = 0.04). Weight of topical steroids reduced in both groups: -0.60 ± 1.3 g/day (35%), SCG and -0.05 ± 1.1 g/day vehicle (p = 0.04). Treatment success, defined as investigator global opinion graded very or moderately effective, was significantly more frequent in SCG group (p = 0.025). Application site discomfort reported by 12.5% of subjects in SCG group and 16.5% in vehicle group.
  
  
  CONCLUSIONS
  SCG 4% cutaneous emulsion provides an effective, well-tolerated, steroid-sparing treatment for AD in children.
authors.affiliation: Dermatology Department, University Hospitals Coventry and Warwickshire NHS Trust , Coventry , UK .
authors.forename: John
authors.initials: J
authors.lastname: Berth-Jones
authors.forename: Ian
authors.initials: I
authors.lastname: Pollock
authors.forename: Ross M R
authors.initials: RM
authors.lastname: Hearn
authors.forename: Sue
authors.initials: S
authors.lastname: Lewis-Jones
authors.forename: Mark
authors.initials: M
authors.lastname: Goodfield
authors.forename: Christopher E M
authors.initials: CE
authors.lastname: Griffiths
authors.forename: Ram
authors.initials: R
authors.lastname: Gulati
authors.forename: Pamela
authors.initials: P
authors.lastname: McHenry
authors.forename: Anthony
authors.initials: A
authors.lastname: Abdullah
authors.forename: Jennifer
authors.initials: J
authors.lastname: Ott
authors.forename: Andrew
authors.initials: A
authors.lastname: Wright
authors.forename: Benjamin
authors.initials: B
authors.lastname: Walker
authors.forename: Michael T
authors.initials: MT
authors.lastname: Stevens
authors.forename: Alan M
authors.initials: AM
authors.lastname: Edwards
mesh_terms: D000287:Administration, Topical; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D004205:Cromolyn Sodium / Q000627:therapeutic use*; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011537:Pruritus / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D018926:Anti-Allergic Agents; D000893:Anti-Inflammatory Agents; D004205:Cromolyn Sodium
keywords: Children; clinical trial; cromolyn; eczema; long term; topical