Table 3 Summary of protocol amendments that impacted on trial design
Protocol | Date | Summary of changes prior to start of recruitment |
|---|---|---|
 V 2.0 | 1 August 2013 | • Eligibility criteria amended to include children with at least one patch of eczema on the trunk or limbs |
Protocol | Date | Summary of changes after start of recruitment |
 V 3.0 | 11 February 2014 | • The number for filaggrin genotype mutations which the lab will be looking for has been increased from 4 to 6, to now also include: ‘up to 6 mutations’ (depending on quantity/quality of DNA) and the additional two are 3702delG and 3673delC |
• Introduction of details of optional qualitative component for study participants (parents and children) to take part in at the end of the 8-month RCT |