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Hydration with topical emollients is the mainstay treatment for mild atopic dermatitis (AD), but few randomized controlled trials have assessed their efficacy in young children.
The purpose of a study published in Journal of the European Academy of Dermatology and Venereology was to assess the efficacy and tolerability of long-term emollient therapy in the treatment of moderate-to-severe xerosis in young children with AD.
In this phase III, multicenter, double-blinded, randomized, vehicle-controlled trial, 251 children between 2 and 6 years with AD-associated xerosis were randomized to the ratio 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. Whereas, responders stopped treatment until reassessment on day-56. Those who relapsed after the discontinuation of treatment were treated open-label with emollient until day-84.
It was observed that 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. More patients were responders with emollient than with vehicle. During the open-label period, discontinuing emollient treatment led to relapse, but improvement reappeared if treatment was restarted with emollient. Regular use of the emollient also yielded improvements in children who did not initially respond. On the other hand, adverse events were similar in the two groups and no treatment-related severe adverse events were reported.
Hence, it was concluded that long-term therapy with emollient is effective and well tolerated for the treatment of xerosis in children with AD.
Source: Journal of the European Academy of Dermatology and Venereology. 2014 Nov;28(11):1456-62.