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A randomised, controlled trial of a 4% cutaneous emulsion of sodium cromoglicate in treatment of atopic dermatitis in children.
- Source :
- Journal of Dermatological Treatment; Jun2015, Vol. 26 Issue 3, p291-296, 6p
- Publication Year :
- 2015
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 09546634
- Volume :
- 26
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Journal of Dermatological Treatment
- Publication Type :
- Academic Journal
- Accession number :
- 108561788
- Full Text :
- https://doi.org/10.3109/09546634.2014.946380