Micropore Closure Kinetics at Various Body Sites
Condition: Healthy
Study type: Interventional

Summary: 
      The study to be performed will define the rate of skin barrier recovery following micropatch
      application to the skin on the upper arm, volar forearm, and abdomen in healthy subjects.
    

Detailed description: 
      Transdermal drug delivery (by way of patches that adhere to the skin and deliver drug in a
      time-dependent fashion) allows for systemic drug delivery through the skin, while avoiding
      many of the side effects and challenges associated with oral or intravenous drug delivery.
      One significant challenge limiting the number of drug compounds that can be transdermally
      delivered is the hydrophobic nature of the skin, which provides a barrier against absorption
      of drug molecules. Micropatches are a specialized type of patch that help drug molecules to
      cross the skin by creating micron-sized channels (also called micropores) in the skin, which
      makes the skin more permeable. Micropatches have been safely used in hundreds of patients for
      administration of drugs and vaccines through the skin. Studies have demonstrated that
      micropatch application is relatively painless and well-tolerated by most patients.

      Following micropatch application, the skin must reseal the micropores in order to restore the
      skin's full barrier function. In young healthy individuals this process takes approximately
      48 to 72 hours when the skin is covered by an occlusive patch. The timeframe is longer in
      older individuals who are >65 years of age. As evidenced by these age-related differences in
      restoration of skin barrier function, biological variation can have a significant effect on
      the skin's response after micropatch application. There are almost no data available
      regarding how race and ethnicity affect skin response to micropatch application. It is
      crucial to better understand how the rates of restoring barrier function vary in different
      racial/ethnic populations. This is very important for reducing potential for variability in
      drug delivery when new micropatches are developed in the future for treating diseases.

      In this study researchers are examining skin characteristics and response to micropatch
      application, but there will be no drugs delivered in this study. Hydration and color will be
      measured to characterize the epidermal properties of individuals of different self-identified
      race and ethnicity. Measurements of trans-epidermal water loss and electrical impedance will
      be used to evaluate the formation of micropores in the skin; the electrical impedance
      measurements will be used to calculate the rate of barrier function repair. All of these skin
      characteristics can be measured using noninvasive methods that are quick and painless.
    

Intervention name(s): Micropatch
Intervention type(s): Device
Intervention description(s): Each micropatch contains 50 tiny projections (800 um in length)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Peer Reviewed Research