Safety
No family sought emergency medical assessment related to the study
intervention. Parent-reported skin infections during the 8-week
intervention period occurred in 5% (6/120) of the IG and 5.7% (8/140)
of the CG. One IG infant was advised to stop applying the emollient
after developing a rash that had a potential temporal relationship with
the emollient and was withdrawn from the study. Two suspected reactions
to the study emollient were investigated and confirmed as having no
relationship.