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Bath Additives for the Treatment of Childhood Eczema

Bath Additives for the Treatment of Childhood Eczema: randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84102309
Enrollment
405
Registered
2013-12-13
Start date
2014-11-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood eczema Skin and Connective Tissue Diseases Atopic dermatitis, unspecified

Interventions

Children will be randomised online to either regular bath emollients prescribed by the GP in addition to standard eczema care, or to standard eczema care without bath emollients. The

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Children aged >1 and <12 years with atopic eczema

Exclusion criteria

Exclusion criteria: 1. Children with inactive or very mild eczema (5 or less on Nottingham Eczema Severity Scale) 2. Children who usually have a bath less than once per week

Design outcomes

Primary

MeasureTime frame
Weekly eczema severity measured by POEM (Patient-Oriented Eczema Measure) questionnaires weekly for 16 weeks.

Secondary

MeasureTime frame
1. Eczema severity over 1 year by administering POEM every 4 weeks from 16 weeks to 12 months. 2. Number of eczema exacerbations resulting in a primary healthcare consultation over 1 year. This will be assessed by a review of participants' primary care records at 1 year, and exacerbations will be defined as consultations where there is mention of eczema and topical steroid has been advised or prescribed. 3. Disease-specific QoL at baseline, 16 weeks and 1 year, measured by DFI (Dermatitis Family Impact), IDQoL (Infants Dermatitis Quality of Life index) and CDLQI (Childrens Dermatology Life Quality Index). 4. Generic QoL as measured by the Child Health Utility 9D (CHU 9D), a paediatric health related quality of life measure for use in economic evaluations, and the Health Utility Index II (HUI2), a utility measure that has been widely used in paediatric research (the UK valuation tariff will be used). 5. Type (strength) and quantity of topical steroid/calcineurin inhibitors prescribed, measured by GP record review at 12 months.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 5, 2026