| Methods |
Parallel group, investigator blind, active control, multicentre randomised controlled trial |
| Participants |
Inclusion criteria: adults (N = 413), mild to very severe eczema (diagnosis criteria: Hanifin and Rajka), age >= 16 years, IGA 2 to 5, TBSA >= 5%.
Exclusion criteria: use nonsteroidal immunosuppressants, light therapy, systemic and topical corticosteroids, topical H1 & H2 antihistamines, topical antimicrobials.
Wash out period: four weeks. |
| Interventions |
pimecrolimus 1.0% BID (n = 203) vs. tacrolimus 0.1% BID (n = 210) for 6 weeks |
| Outcomes |
1. Efficacy: number of participants achieving clear or almost clear eczema (IGA); median percentage (%) of reduction in EASI from baseline; mean percentage (%) of reduction in BSA
2. Safety and tolerability: total WDs; WDs due to lack of efficacy; WDs due to ADEs; numbers of participants have: any adverse event, skin infection, bacterial skin infection, viral skin infection, and skin burning |
| Notes |
This paper reports separate data for three trials. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
