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Clinical Trial Summary

The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds.

Clinical Trial 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 highly efficient barrier against the absorption of drug molecules. Micropatches are small patches with tiny projections that are a minimally invasive way to allow drug molecules to cross the skin by creating micron-sized channels (also called micropores) in the skin, thereby increasing its permeability. Micropatches have been safely used in hundreds of patients for administration of drugs and vaccines through the skin. Studies have demonstrated that micropatch treatment is relatively painless and well-tolerated by most patients. Following micropatch treatment, the skin must heal the micropores. In young healthy individuals this process takes approximately 48 to 72 hours when the skin is covered by an occlusive patch. One of the factors that may also affect micropore healing time is the depth of the micropores in the skin immediately after micropatch treatment. There are almost no data available regarding how race and ethnicity affect the depth of micropores after micropatch application. It is important to study differences in micropore depth so we can better understand why rates of micropore closure vary in different racial/ethnic populations. Without this information the potential for variability in drug delivery is high. In this study we will objectively measure skin color with a colorimeter to characterize the epidermal properties of individuals of different self-identified race and ethnicity. Measurements of trans-epidermal water loss will be used to evaluate formation of micropores in the skin; electrical impedance measurements will be used to estimate rates of micropore closure. We will visualize the micropores created after micropatch treatment with the use of an optical coherence tomography instrument that will allow us to calculate epidermal thickness and micropore depth. All of these skin characteristics can be measured using noninvasive methods that are quick and painless. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04867733
Study type Interventional
Source University of Iowa
Contact Jamie Carr
Phone 319-678-8089
Email [email protected]
Status Recruiting
Phase N/A
Start date April 1, 2021
Completion date April 1, 2023

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