FDA recommends conducting a comparative clinical endpoint bioequivalence study in the treatment of mild to moderate AD comparing the test product versus reference standard and placebo (vehicle) control, each applied as a thin layer twice daily to the affected area(s) up to 20% body surface area (BSA). The primary endpoint is the proportion of subjects with treatment success (a grade of clear or almost clear; a score of0 or 1 with a ≥ 2-grade improvement from baseline, within the treatment area) based on the Investigator’s Global Assessment (IGA) of Disease Severity (see Table 1) at the end of treatment (study Day 15).