Impact of providing specific advice on how long to apply topical corticosteroids (TCSs) for during an eczema flare-up, compared to no specific advice on disease control, eczema symptoms and quality of life in children and adults with eczema: an online, superiority randomised controlled trial
Eczema
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 for 2 days after the skin is eczema-free. No specific advice on duration of applying TCS (treat flare-ups as usual): • Use of TCS during a flare-up as the participant normally would. Randomisation will be carried out by the participant using a secure, online randomisation system. Participants will be randomised 1:1 to either the intervention group (specific advice) or the control group (treat flare-ups as usual) using a minimisation algorithm with a probabilistic element balancing on the following factors: • Eczema severity POEM score (0-7 mild, 8-16 moderate, 17-28 severe). • Age (<4 years, 4-11 years, 12-15 years, 16-25 years, 26-55 years, >55 years) • Potency of TCS (mild, moderate, potent) Following randomisation, participants will be provided with intervention instructions detailing how long they should treat their eczema flare-up for according to their allocation. Participants should follow this advice when they have a flare-up during the 4 months they are in the study. Participants will be advised to use their usual prescribed TCS and will remain under the care of their usual healthcare professional.
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)
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.