Outcomes’ success criteria
As a therapeutic clinical trial, enrolling dogs with AD, EPIT efficacy
was based on primary outcomes’ success, following the ICADA’s COSCAD’18
recommendations45. Nevertheless, some considerations
were addressed so that the defined criteria covered all dogs’ clinical
situation. Therefore, for dogs with an initial moderate-to-severe AD,
success was defined as the percentage of dogs achieving the
normal-to-mild range at six months, and for dogs with an initial mild
AD, returning to the normal status45. Exceptionally,
maintenance of lesional score at six months was considered successful,
for dogs with an initial normal lesional status, but a mild-to-severe
pruritus. OGATE was successful when rated as good-to-excellent.
Secondary outcomes’ success was defined as the percentage of dogs with
improved QoL classification at six months (i.e. decreased QoL score),
and, for allergen-specific IgE serology, the percentage of dogs that
fully or partially desensitised to allergens.
EPIT was deemed safe if no systemic or severe local adverse events
occurred.
Owner’s adherence considered protocol compliance and attendance at study
appointments.