A Randomized Double-blind Study on the Efficacy of 20% VCO Cream versus a Commercial Emollient for Atopic Dermatitis in Children

Abstract

Objective. To assess the effects of a formulated 20% VCO cream on symptoms of atopic dermatitis in children relative to a commercial emollient with skin barrier protective property indicated for dry, itchy skin.
Methods. In a randomized, double-blind, pilot study, pediatric patients with atopic dermatitis according to the modified Hanifin and Rajka criteria were enrolled and assigned to use either formulated VCO cream or commercial emollient. Treatments were applied twice daily for four (4) weeks. Outcome measures were investigator- and patientassessed clinical efficacy based on Severity Scoring of Atopic Dermatitis (SCORAD) severity index, and incidences of documented adverse events.
Results. Twenty-nine patients were recruited in the study and in an intention-to-treat analysis, mean SCORAD indices were reduced by 41.79% and 29.77% in the VCO cream group and commercial emollient group, respectively. Both study groups showed significant reduction in the mean subjective SCORAD index relating to pruritus and sleep loss. Mean objective SCORAD index, based on intensity items and total surface with eczema, was also significantly improved in the VCO cream group after four weeks of product usage. The study products were generally well-tolerated, with minor adverse events reported for the VCO cream group.
Conclusion. Results of the study suggest that application of VCO at 20% in a cream formulation is more effective than the tested commercial emollient in alleviating symptoms of AD in children.