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Abstract

Background

Hydration with topical emollients forms the backbone of treatment for mild atopic dermatitis (AD), but few randomized controlled trials have assessed their efficacy in young children.

Objectives

Assess the efficacy and tolerability of long-term emollient therapy in the treatment of moderate to severe xerosis in young children with AD.

Methods

This was a phase III, multicentre, double-blind, randomized, vehicle-controlled trial. Children (n = 251) aged 2–6 years with AD-associated xerosis were randomized 1 : 1 to a 28-day treatment with an emollient combining glycerol and paraffin or its vehicle. Non-responders at the end of the double-blind period were treated open label with emollient until day 84. Responders stopped treatment until reassessment on day 56. Those who relapsed after stopping treatment were treated open label with emollient until day 84.

Results

During the double-blind period, xerosis score (XS) of the scoring atopic dermatitis (SCORAD) index, objective SCORAD and visual analogue score decreased and skin hydration increased more in the emollient group than in the vehicle group (< 0.001 for all measures). More patients were responders with emollient than with vehicle (66.1% vs. 45.6%, < 0.001). During the open-label period, stopping emollient treatment led to relapse but improvement returned if treatment was restarted with emollient. Regular use of the emollient also yielded improvement in children who did not initially respond. Adverse events were similar in the two groups, and no treatment-related severe adverse events were reported.

Conclusions

Long-term therapy with emollient is effective and well tolerated for the treatment of xerosis in children with atopic dermatitis.