| Methods |
Parallel group, double blind, placebo control, international multicentre, randomised controlled trial |
| Participants |
Inclusion criteria: adults (N = 198), mild to moderate eczema, age: 18 to 81 years, IGA 2 or 3, BSA >= 5%, moderate to severe pruritus (pruritus score 2 or 3).
Exclusion criteria: skin diseases, allergy, infections, poor response to topical tacrolimus, immunocompromised, malignant history, breast‐feeding, pregnant, not use medically approved contraception.
Wash out period: topical medication for pruritus relief or antibiotic therapy < seven days, anti‐pruritus or sedatives medications < two weeks, systemic or phototherapy for eczema < one month. |
| Interventions |
pimecrolimus 1.0%BID (n = 100) vs. emollients BID (n = 98) for 1 week |
| Outcomes |
1. Efficacy: number of participants achieving mild or absent pruritus, number of participants improved by at least one pruritus score
2. Safety and tolerability: total WDs, WDs due to lack of efficacy, WDs due to ADEs, numbers of participants experiencing any skin infections and application site skin burning. |
| Notes |
The total duration was six weeks, but we did not include data for the five‐week open‐label trial. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Low risk |
A ‐ Adequate |
