Eczema Skin and Connective Tissue Diseases
Conditions
Interventions
Randomisation will be carried out by the participant using a secure, online randomisation system. Participants will be randomised 1:1 to either weekly bathing or daily bathing using a minimisation alg
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =1 year with self-report of eczema (syn. atopic dermatitis, atopic eczema) 2. Usual residence in the UK 3. Able and willing to give informed consent (or parent/legal guardian able and willing to give informed consent for children under 16 years)
Exclusion criteria
Exclusion criteria: 1. None or very mild eczema symptoms (POEM score =2) 2. Eczema only present on hands (likely to be hand eczema or contact dermatitis); limited to locations where skin exposed to nickel e.g. jewellery (likely to be contact dermatitis); or eczema only around varicose veins (likely to be varicose eczema) 3. Started a new eczema treatment (including antibiotics for eczema) other than emollients in the last 4 weeks 4. Taking part in another eczema intervention trial 5. Unable or unwilling to change bathing practices for 4 weeks 6. Planning to swim more than twice a week in the next 4 weeks (including surfing, scuba diving etc) 7. Member of household already participating in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema symptoms measured using the Patient-Oriented Eczema Measure (POEM) at baseline and weekly over 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The study will include the Harmonising Outcome Measures for Eczema (HOME) core outcome set (https://www.homeforeczema.org). 1. Itch intensity measured using the Peak Pruritis Numerical Rating Scale (NRS) 22 24-hour peak itch - one item, scored 0 to 10. Assessed at baseline and 4 weeks. 2. Eczema control measured using the Recap of atopic eczema (RECAP) – 7 items, scored 0 to 28. Assessed at baseline and 4 weeks. 3. Skin-specific quality of life measured using the Infants' Dermatitis Quality of Life Index (IDQoL) (under 4 years), Children’s Dermatology Life Quality Index (CDLQI) (from 4 years to 15 years) or Dermatology Life Quality Index (DLQI) (16 years and over), depending on age – 10 items, scored 0 to 30. Assessed at baseline and 4 weeks. 4. Use of usual eczema treatments assessed weekly over 4 weeks by questionnaire: 4.1. Number of days in the last week flare control creams (topical corticosteroids or calcineurin inhibitors) used – this outcome will be used as an indication of days with eczema flares 4.2. Number of days in the last week moisturisers (emollients) used 5. Proportion of participants who achieve an improvement in POEM at week 4 of =3 points compared to baseline 6. Global change in eczema compared to baseline. Assessed by questionnaire at week 4. 7. Adverse events: the researchers do not anticipate adverse events related to changing bathing practices but will collect whether participants changed their eczema treatments or sought advice from a health care provider as a result of a worsening of the eczema. Assessed by questionnaire at week 4. Additional variables will be collected to inform analysis and interpretation of the trial. These include: 1. Minimisation variables, prior belief on the frequency of bathing and eczema symptoms, demographics, UK Diagnostic Criteria for Eczema and usual bathing practices (e.g. usual temperature of the water, use of shampoo, use of emollient wash products, and application of emollients/flare control creams | — |
Countries
England, United Kingdom
Contacts
Public ContactEleanor Harrison
Outcome results
None listed