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 (P < 0.001 for all measures). More patients were responders with emollient than with vehicle (66.1% vs. 45.6%, P < 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.
RCT Entities:
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 (P < 0.001 for all measures). More patients were responders with emollient than with vehicle (66.1% vs. 45.6%, P < 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.
Authors: Jung Eun Kim; Hyun Jeong Kim; Bark-Lynn Lew; Kyung Ho Lee; Seung Phil Hong; Yong Hyun Jang; Kui Young Park; Seong Jun Seo; Jung Min Bae; Eung Ho Choi; Ki Beom Suhr; Seung Chul Lee; Hyun Chang Ko; Young Lip Park; Sang Wook Son; Young Jun Seo; Yang Won Lee; Sang Hyun Cho; Chun Wook Park; Joo Young Roh Journal: Ann Dermatol Date: 2015-10-02 Impact factor: 1.444
Authors: May El Hachem; Giuseppe Di Mauro; Roberta Rotunno; Simona Giancristoforo; Cristiana De Ranieri; Carla Maria Carlevaris; Maria Carmen Verga; Iride Dello Iacono Journal: Ital J Pediatr Date: 2020-01-30 Impact factor: 2.638