| Methods |
Parallel group, double blind, placebo control, multicentre, randomised controlled trial (flare prevention study) |
| Participants |
Inclusion criteria: children (N =185), severe eczema (diagnosis criteria: Rajka & Langeland), age: 2 to 17 years, eczema score 8 or 9, responded to 21 days of treatment with prednicarbate cream 0.25%.
Exclusion criteria: phototherapy, systemic or topical therapy or systemic corticosteroid prior to study entry which could have an effect on eczema. |
| Interventions |
pimecrolimus 1.0 % BID (n=95) vs. vehicle BID (n=89) for 24 weeks. Short‐term acute flares were treated with topical prednicarbate cream 0.25% BID. |
| Outcomes |
Safety and tolerability: total WDs, WDs due to lack of efficacy, WDs due to ADEs. |
| Notes |
Report from Novartis clinical trial results website. This study involved participants who responded to topical corticosteroid treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
