Long-term use of a 4% sodium cromoglicate cutaneous emulsion in the treatment of moderate to severe atopic dermatitis in children

Abstract

Introduction: 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). Materials and 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.

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

Acknowledgements

The authors acknowledge the contribution made by the following: Dr R Pedersen, Ullevål Stadion, Oslo, Norway: Dr A Milligan and staff at the Dermatology Department, Leicester Royal Infirmary who entered subjects. The staff at Smerud Medical Research of Oslo, Norway, who monitored the trial and conducted the statistical analyses; staff at Medevol Ltd. of Belfast, who recruited doctors in Northern Ireland to enter 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.