| Methods |
Parallel group, double blind, placebo control, international multicentre, randomised controlled trial |
| Participants |
Inclusion criteria: children and adults (N = 200), mild to moderate facial eczema (diagnosis criteria: Hanifin and Rajka), age: >= 12 years, facial IGA 2 to 3 based on assessment on the face only and excluding the ears and the neck.
Exclusion criteria: <= 30% BSA, pregnant or breast‐feeding women, concurrent skin disease, immunocompromised, poor response, hypersensitivity.
Wash out period: phototherapy or systemic therapy: four weeks, investigational drugs: eight weeks. |
| Interventions |
pimecrolimus 1.0% BID (n = 101) vs. vehicle BID (n = 99) for 6 weeks |
| Outcomes |
1. Efficacy: number of participants achieving clear or almost clear facial eczema (IGA) and achieving mild or absent pruritus
2. Safety and tolerability: total WDs, WDs due to lack of efficacy, WDs due to ADEs, incident rate of ADEs of different organ systems (events/days). |
| Notes |
Report from Novartis clinical trial results website. We did not include data for the 6‐week, open‐label period. The numbers of participants experiencing ADEs are not available. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
