Use of Imaging and Digital Image Analysis Software/s to Evaluate Transdermal Irritation and Non - inferiority of Generic Transdermal Products (U01)

Use of “trained observers” for clinical evaluation of transdermal irritation has the potential for observer bias and variability in assessment since the various transdermal systems that are applied on subjects for such studies are usually visually dissimilar. Use of digital images and image analysis software/s has the potential to enhance consistency and reliability of the measurements compared to visual assessment. The purpose of this study is to help evaluate if digital imaging can be used to quantify transdermal irritation and for non-inferiority analysis of generic transdermal systems.