| Methods |
Parallel group, double blind, placebo control, multicentre, randomised controlled trial |
| Participants |
Inclusion criteria: infants and children (N = 106), mild to moderate eczema, age: 3 months to 18 years, IGA score 2 to 3.
Exclusion criteria: not stated.
Wash out period: not stated. |
| Interventions |
pimecrolimus 1.0% BID (n=71) vs. vehicle BID (n = 35) for three weeks |
| Outcomes |
1. Efficacy: numbers of participants achieving clear or almost clear eczema (IGA), achieving complete or well controlled eczema (PGA), and achieving mild or absent pruritus; median percentage (%) of reduction in EASI from baseline
2. Safety and tolerability: total WDs; number of participants experiencing application site skin burning. |
| Notes |
Abstract only, we did not include data for the 24‐week, open‐label, noncomparative trial period. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
