| Methods |
Parallel group, double blind, placebo control, international multicentre, randomised controlled trial |
| Participants |
Inclusion criteria: children and adults (N = 73), mild to moderate eczema, age: 2 to 50 years, BSA >=5%, poor response to treatment with prednicarbate emollient cream.
Exclusion criteria: concurrent skin diseases, systemic malignancy, active lymph proliferation, hypersensitivity.
Wash out period: phototherapy, systemic or topical therapy: four weeks, systemic retinoid or investigational drugs: eight weeks, systemic or topical antibiotics: two weeks. |
| Interventions |
pimecrolimus 1.0% BID (n=47) vs. vehicle BID (n=26) for 6 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; mean reduction in EASI from baseline; number of participants' eczema improved by at least one IGA score
2. Safety and tolerability: total WDs, WDs due to lack of efficacy, WDs due to ADEs, numbers of participants experiencing any ADEs, skin infections, viral skin infections, application site skin burning. |
| Notes |
Report from Novartis clinical trial results website. This study involved participants who had poor response to topical corticosteroid treatment. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
