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.