Randomised controlled trial of short bursts of a potent topical corticosteroid versus prolonged use of a mild preparation for children with mild or moderate atopic eczema

Abstract

Objective To determine whether a three day burst of a potent corticosteroid is more effective than a mild preparation used for seven days in children with mild or moderate atopic eczema. Design Randomised, double blind, parallel group study of 18 weeks' duration. Setting 13 general practices and a teaching hospital in the Nottingham area. Participants 174 children with mild or moderate atopic eczema recruited from general practices and 33 from a hospital outpatient clinic. Interventions 0.1% betamethasone valerate applied for three days followed by the base ointment for four days versus 1% hydrocortisone applied for seven days. Main outcome measures Primary outcomes were total number of scratch-free days and number of relapses. Secondary outcomes were median duration of relapses, number of undisturbed nights, disease severity (six area, six sign atopic dermatitis severity scale), scores on two quality of life measures (children's life quality index and dermatitis family impact questionnaire), and number of patients in whom treatment failed in each arm. Results No differences were found between the two groups. This was consistent for all outcomes. The median number of scratch-free days was 118.0 for the mild group and 117.5 for the potent group (difference 0.5, 95% confidence interval − 2.0 to 4.0, P = 0.53). The median number of relapses for both groups was 1.0. Both groups showed clinically important improvements in disease severity and quality of life compared with baseline. Conclusion A short burst of a potent topical corticosteroid is just as effective as prolonged use of a milder preparation for controlling mild or moderate atopic eczema in children.

Scoping systematic review of treatments for eczema

“…Six of the trials 113,[116][117][118]121 had > 100 participants and six 112,114,115,119,120,122 had ≤ 50 participants. The treatment regimens varied, with one trial providing 7 days of treatment as required over an 18-week period 116 one trial providing either twice daily treatment for 8 weeks or twice daily treatment for four consecutive days per week for 8 weeks, 122 and the other trials providing continuous treatment for periods from 2 weeks to 42 days. [112][113][114][115][117][118][119][120] An additional four trials [123][124][125][126] were reported that compared a new active treatment against a topical corticosteroid as the 'standard treatment' comparator.…”

“…A total of 12 trials [112][113][114][115][116][117][118][119][120][121][122] were reported from 2000 onwards, with two trials reported together in one report. 113 Ten of these trials compared novel topical corticosteroids with standard topical corticosteroids and one trial 118 compared a topical corticosteroid with and without the addition of a penetration-enhancing drug.…”

“…This trial report was very short and there were very few details provided about the trial. Nine of these trials [112][113][114][115][116][117]122 compared treatments exclusively in children and three trials [118][119][120] did not report the age of the participants. Six of the trials 113,[116][117][118]121 had > 100 participants and six 112,114,115,119,120,122 had ≤ 50 participants.…”

“…Nine of these trials [112][113][114][115][116][117]122 compared treatments exclusively in children and three trials [118][119][120] did not report the age of the participants. Six of the trials 113,[116][117][118]121 had > 100 participants and six 112,114,115,119,120,122 had ≤ 50 participants. The treatment regimens varied, with one trial providing 7 days of treatment as required over an 18-week period 116 one trial providing either twice daily treatment for 8 weeks or twice daily treatment for four consecutive days per week for 8 weeks, 122 and the other trials providing continuous treatment for periods from 2 weeks to 42 days.…”

Atopic Dermatitis

“…Less potent topical steroids such as hydrocortisone can also be employed to children less than 1 year old. Different therapeutic schemes have been established: initial treatment should be with moderate to high potent steroids followed by a dose reduction or an exchange to a lower potency preparation 75 .…”