| Methods |
Parallel group, double blind, placebo control, international multi‐centre, randomised controlled trial
(flare‐preventing study) |
| Participants |
Inclusion criteria: children (N = 711), mild eczema (diagnosis criteria: Williams et al.), age: 2 to 17 years, TBSA >= 5%, IGA >= 2.
Exclusion criteria: infections that required prohibited medication or that could affect evaluation of skin.
Wash out period: phototherapy or systematic therapy: one month, topical therapy: seven days, systematic antibiotics: two weeks. |
| Interventions |
pimecrolimus 1.0% BID (n = 474) vs. emollients BID (n = 237) for 52 weeks and followed up to 53 weeks. Short‐term flares were treated with moderately potent topical steroids (0.02% difluprednate, 0.25% prednicarbate, 0.1% hydrocortisone butyrate, 0.05% clobetasone butyrate, 0.02% triamcinolone acetonide, 0.1% hydrocortisone valerate). |
| Outcomes |
1. Efficacy: numbers of participants achieving no flare and not using TS; percentage (%) of mean duration for TS use; number of participants using antihistamine; mean decrease in DLQI score; mean PIQoL‐AD score.
2. Safety and tolerability: total WDs, WDs due to lack of efficacy. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
