Potent topical corticosteroid is more effective compared to mild potency in children in primary care with a moderate flare-up of atopic dermatitis; results of a randomized controlled trial.

Problem

Topical corticosteroids (TCS) of different potencies are the main pharmacological treatment to control atopic dermatitis (AD) in general practice. Different initial therapy strategies are advocated for a disease flare-up: starting with a short burst of high-potency TCS, starting with the lowest TCS potency possible, and starting with a TCS tailored to severity. To our knowledge, no study has assessed the effectiveness of treatment with mild TCS versus a potent TCS in children in primary care with moderate AD. Therefore, we conducted the Rotterdam Eczema Study to assess the effectiveness of a potent TCS as an initial treatment in children with a moderate AD flare-up in primary care, compared to starting with a mild TCS. The primary objective was to investigate whether starting with a potent TCS is superior to starting with a mild TCS for long-term disease control (6-months follow-up).

Approach

The Rotterdam Eczema Study was an observational prospective cohort study with an embedded pragmatic multi-centre open-label randomized controlled trial. We chose this design since it can be difficult to randomize children who are experiencing a flare-up in primary care when they visit the GP. Our approach allowed us to monitor the AD-affected children who were already enrolled in the cohort and incorporate them into the study immediately in the event of a flare-up. If cohort participants experienced a moderate flare-up (ie, need to intensify topical treatment) from the child’s and/or parents’ point of view of AD and a three-item-severity score from 3 to <6 scored by their GP) during cohort follow-up, they were randomised to either the intervention group, a strong TCS (class III, fluticasone propionate 0.05%), or the control group, a mild TCS (class I, hydrocortisone acetate 1%). : We measured outcomes at baseline and 1, 4 and 24 weeks. The primary outcome was AD-related symptoms (POEM score) measured over 24 weeks of follow-up. Secondary outcomes included the Eczema Area and Severity Index, the Investigators Global Assessment, quality of life, Patient Global Assessment, Numeric Itch Intensity Score and topical corticosteroid use.

Findings

The primary outcome showed a significant difference in the POEM score over 24 weeks of follow-up between the intervention group (n=17) and control group (n=15) (3.3 versus 9.4, p=0.023). Also, potent TCS significantly improved the POEM at 1 week (5.5 versus 12.0, p=0.042) and over 4 weeks (4.4 versus 12.7, p=0.030). Improvement in the QoL was significant at 4 weeks (1.0 vs. 4.5, p=0.014) and 24 weeks (0.0 vs. 2.0, p=<0.000).

Consequences

Despite the small sample size, the data suggest clinical benefit from starting with a potent TCS compared to a mild TCS when a flare-up of AD is moderate.