Tolerability Study of the Application of a 3M Microstructure Transdermal System

The purpose of this study is to evaluate the safety and tolerability of an experimental
device that introduces microscopic channels into the skin. Creating microscopic channels in
the skin allows for better absorption of various medications applied to the skin, and this
study will determine if the study device offers a tolerable method by which to introduce
these holes. The study population will include 54 individuals, ages 18-74 years old, with a
roughly equal distribution of skin colors. Each subject will have a total of three visits 24
hours apart from one another. The study device will be applied at the Baseline and Day 1
visits. At various timepoints before and after device application, skin assessments for
irritation will be completed using a 7-point Skin Reaction Scale and photographs will be
taken. Subjects will report pain associated with device application using a standardized
pain scale. At the baseline visit, a member of the research staff will administer
applications of the study device on the side of the subject's forehead, temple and the area
below and to the side of the nose on randomly selected sides of the face. The side of the
face at each location not receiving application of the study device will receive
applications of a "dummy" device. Subjects will not be informed of which device is the study
device and which is the "dummy" device. At the Day 1 visit, a member of the research staff
will administer study device applications to the center of the subject's forehead. The
subject will also self-apply the study device to the chin, under the instruction of the
research staff member. At the Day 2 visit, final skin assessments will be made and the
subject will be evaluated and treated for any persistent skin irritation. Differences in
skin irritation between sites of study device application and "dummy" device application
will be determined, as well as several other endpoints.