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Objectives: To determine the clinical and cost-effectiveness of including emollient bath additives in the management of childhood eczema. Trial design: Pragmatic randomised open-label superiority trial with two parallel groups. Setting and recruitment: 96 general practices in Wales, West of England and Southern England. Invitation by personal letter or opportunistically by usual clinical team. Participants: Children were eligible to participate if aged over 12 months and less than 12 years, fulfilling UK Diagnostic Criteria for Atopic Dermatitis. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once a week, or whose carers were not willing to accept randomisation. 483 were randomised and one withdrew, leaving 482 children in the trial: 51% female, 84% white, mean age 5 years. Interventions: The intervention group were prescribed emollient bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and were given standardised advice on how to wash. Primary outcome: Eczema control measured by Patient Oriented Eczema Measure (POEM, range 0-28) weekly for 16 weeks. Secondary outcomes: Eczema severity over 1 year (4-weekly POEM from baseline to 52 weeks); number of eczema exacerbations resulting in primary healthcare consultation; disease-specific quality of life (QOL) (Dermatitis Family Impact); generic QoL (Child Health Utility-9D); resource utilisation; type and quantity of topical corticosteroid/calcineurin inhibitors prescribed. Randomisation: 483 children were randomised (1:1) using online software, stratified by recruiting centre. Results: 95.6% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 76.8% (370/482) of participants completed questionnaires for more

Objectives: To determine the clinical and cost-effectiveness of including emollient bath additives in the management of childhood eczema. Trial design: Pragmatic randomised open-label superiority trial with two parallel groups. Setting and recruitment: 96 general practices in Wales, West of England and Southern England. Invitation by personal letter or opportunistically by usual clinical team. Participants: Children were eligible to participate if aged over 12 months and less than 12 years, fulfilling UK Diagnostic Criteria for Atopic Dermatitis. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once a week, or whose carers were not willing to accept randomisation. 483 were randomised and one withdrew, leaving 482 children in the trial: 51% female, 84% white, mean age 5 years. Interventions: The intervention group were prescribed emollient bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and were given standardised advice on how to wash. Primary outcome: Eczema control measured by Patient Oriented Eczema Measure (POEM, range 0-28) weekly for 16 weeks. Secondary outcomes: Eczema severity over 1 year (4-weekly POEM from baseline to 52 weeks); number of eczema exacerbations resulting in primary healthcare consultation; disease-specific quality of life (QOL) (Dermatitis Family Impact); generic QoL (Child Health Utility-9D); resource utilisation; type and quantity of topical corticosteroid/calcineurin inhibitors prescribed. Randomisation: 483 children were randomised (1:1) using online software, stratified by recruiting centre. Results: 95.6% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 76.8% (370/482) of participants completed questionnaires for more

Objectives: To determine the clinical and cost-effectiveness of including emollient bath additives in the management of childhood eczema. Trial design: Pragmatic randomised open-label superiority trial with two parallel groups. Setting and recruitment: 96 general practices in Wales, West of England and Southern England. Invitation by personal letter or opportunistically by usual clinical team. Participants: Children were eligible to participate if aged over 12 months and less than 12 years, fulfilling UK Diagnostic Criteria for Atopic Dermatitis. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once a week, or whose carers were not willing to accept randomisation. 483 were randomised and one withdrew, leaving 482 children in the trial: 51% female, 84% white, mean age 5 years. Interventions: The intervention group were prescribed emollient bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and were given standardised advice on how to wash. Primary outcome: Eczema control measured by Patient Oriented Eczema Measure (POEM, range 0-28) weekly for 16 weeks. Secondary outcomes: Eczema severity over 1 year (4-weekly POEM from baseline to 52 weeks); number of eczema exacerbations resulting in primary healthcare consultation; disease-specific quality of life (QOL) (Dermatitis Family Impact); generic QoL (Child Health Utility-9D); resource utilisation; type and quantity of topical corticosteroid/calcineurin inhibitors prescribed. Randomisation: 483 children were randomised (1:1) using online software, stratified by recruiting centre. Results: 95.6% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 76.8% (370/482) of participants completed questionnaires for more

Objectives: To determine the clinical and cost-effectiveness of including emollient bath additives in the management of childhood eczema. Trial design: Pragmatic randomised open-label superiority trial with two parallel groups. Setting and recruitment: 96 general practices in Wales, West of England and Southern England. Invitation by personal letter or opportunistically by usual clinical team. Participants: Children were eligible to participate if aged over 12 months and less than 12 years, fulfilling UK Diagnostic Criteria for Atopic Dermatitis. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) were excluded, as were children who bathed less than once a week, or whose carers were not willing to accept randomisation. 483 were randomised and one withdrew, leaving 482 children in the trial: 51% female, 84% white, mean age 5 years. Interventions: The intervention group were prescribed emollient bath additives by their usual clinical team and were asked to use them regularly for 12 months. The control group were asked to use no bath additives for 12 months. Both groups continued with standard eczema management and were given standardised advice on how to wash. Primary outcome: Eczema control measured by Patient Oriented Eczema Measure (POEM, range 0-28) weekly for 16 weeks. Secondary outcomes: Eczema severity over 1 year (4-weekly POEM from baseline to 52 weeks); number of eczema exacerbations resulting in primary healthcare consultation; disease-specific quality of life (QOL) (Dermatitis Family Impact); generic QoL (Child Health Utility-9D); resource utilisation; type and quantity of topical corticosteroid/calcineurin inhibitors prescribed. Randomisation: 483 children were randomised (1:1) using online software, stratified by recruiting centre. Results: 95.6% (461/482) of participants completed at least one post-baseline POEM, so were included in the analysis, and 76.8% (370/482) of participants completed questionnaires for more