Eczema Skin and Connective Tissue Diseases
Conditions
Interventions
The study is an “advice trial” testing two advice strategies:
Specific advice on duration of applying topical corticosteroids (TCS) (treat flare-ups for longer):
• Use of TCS during a flare-up and f
Sponsors
Nottingham University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
1 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged =1 year with self-report of eczema (syn. Atopic dermatitis, atopic eczema) 2. Used topical corticosteroid on a total of at least 3 days to manage eczema flare-up in the last 8 weeks 3. Willing to change how currently using TCS treatments whilst in the trial 4. Usual residence in the UK 5. 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. Using a TCS preparation that includes antibiotics or antifungal (and have no other TCS available), as these products are not intended for long-term use. 2. Diagnosis unlikely to be atopic eczema: only present on hands (likely to be hand eczema or contact dermatitis); limited to locations where skin is exposed to nickel, e.g. jewellery (likely to be contact dermatitis); eczema only around varicose veins (likely to be varicose eczema). 3. Taking part in another eczema intervention trial. 4. Member of household already participating in this trial. 5. Eczema only present on the scalp (as this requires different topical steroid formulations) and/or only at sensitive body sites (e.g. groin, armpits or face (as the advice being tested is not applicable to treatment at sensitive sites, which may require a different potency and duration of treatment)). 6. Using TCSs classed as super potent (i.e. Dermovate, clobetasol propionate 0.05%) - to ensure participant safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema control is measured using the Recap of atopic eczema (RECAP) questionnaire, which includes 7 items (scored 0 to 28) assessed weekly over 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eczema symptoms measured using the Patient Oriented Eczema Measure (POEM), which includes 7 items (scored 0 to 28), assessed monthly 2. Total days of topical corticosteroids (TCS) used (days of TCS use each week during 0 to 7 days) measured using a questionnaire weekly 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) – 10 items, scored 0 to 30, at baseline and week 16 4. The number of weeks when TCS were not used measured using data collected from the use of TCS questions assessed by questionnaire weekly, at one timepoint 5. The number of well-controlled weeks, defined as the number of weeks with Recap score <6, measured using data collected from the RECAP questionnaire, at one timepoint 6. Global change in eczema from baseline measured using data collected from the POEM questionnaire at week 16 7. Adverse events measured using a questionnaire which records the following monthly: 7.1. Contact with a healthcare professional (HCP) because of a worsening of the eczema 7.2. Contact with HCP due to concerns about side effects Additional information will be collected to inform the analysis and interpretation of the trial, including: 1. Minimisation variables, prior belief in intervention strategy, demographics, UK Diagnostic Criteria for Eczema measured using a questionnaire at baseline only 2. Potency of TCS currently used on body, number of days TCS used to treat last flare-up, use of TCS to prevent flare-ups, strategy for starting TCS, attitudes towards use of TCS, sensory issues that might influence use of eczema treatments, use of systemic eczema medications (not including antihistamine), use of other steroid formulations (for any condition) measured using a questionnaire at baseline only 3. Flares used to assess adherence measured using a questionnaire mon | — |
Countries
England, United Kingdom
Contacts
Public ContactEleanor Harrison
Outcome results
None listed