Tolerability Study of the Application of a 3M Microstructure Transdermal System
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    


Intervention name(s): Transdermal Microchannel Skin System; Sham device
Intervention type(s): Device; Device
Intervention description(s): A member of the research staff will apply the study device to the subject's lateral forehead, temple and nasolabial area on randomly selected sides of the face, 3 times at each anatomical location, for a total of 9 applications. All subjects will also receive 9 adjacent applications to the central forehead, and they will self-administer 3 adjacent applications to the chin under instruction of study staff.; The side not receiving application of the study device at each anatomical location will receive a comparable number of applications of a sham device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: needles/adverse effects; administration, cutaneous; erythema; pain measurement; Safety; Microstructure Transdermal System