A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children

ABSTRACT

Introduction: 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.

Materials and 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.

• Children
• clinical trial
• cromolyn
• eczema
• long term
• topical

Acknowledgements

The authors wish to acknowledge the contribution made by the following people to the completion of this study:

Personnel at SynteractHCR, United Kingdom, Limited and SynteractHCR Deutschland GmbH, who identified the centres and monitored and analysed the study.

Dr. N. Morar at Chelsea and Westminster Hospital NHS Truat who entered subjects.

Drs. E. E. A. Abdulhakim, H. Shaw, H. Thomas all of Synexus Dedicated Research Centres, who also entered subjects.

Declaration of interest

A. M. Edwards and M. T. Stevens are consultants to the manufacturers of the 4% SCG emulsion and vehicle used in this study.