| Methods |
Parallel group, double blind, placebo control, multicentre, randomised controlled trial (flare‐preventing study) |
| Participants |
Inclusion criteria: adults (N = 173), mild to moderate eczema, age: 16 to 65 years, TBSA <= 5%, IGA >= 2.
Exclusion criteria: history of malignant, active skin infection, systemic infections, other skin conditions.
Wash out period: phototherapy or systemic therapy: four weeks, antibiotics, antiviral or antifungal therapy: two weeks, topical therapy or systemic antiallergic therapy: seven days. |
| Interventions |
pimecrolimus 1.0% BID (n = 86) vs. vehicle BID (n = 87) for 26 weeks. Short‐term acute flares were treated with topical corticosteroids and/or tacrolimus hydrate ointment BID. |
| Outcomes |
1. Efficacy: numbers of participants achieving no flare; median duration (days) to first flare of eczema.
2. Safety and tolerability: total WDs, WDs due to lack of efficacy, WDs due to ADEs, number of participants experiencing any ADEs. |
| Notes |
Report from Novartis clinical trial results website. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
