NCT04867733

Visualizing Dermal Micropores With OCT

Evaluating Racial and Ethnic Differences in Dermal Micropore Formation Using Optical Coherence Tomography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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 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 investigators 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 the investigators will objectively measure skin color with a colorimeter to characterize the epidermal properties of individuals of different self-identified races and ethnicities. 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. The investigators will visualize the micropores created after micropatch treatment with the use of an optical coherence tomography instrument that will allow for calculation of epidermal thickness and micropore depth. All of these skin characteristics can be measured using noninvasive methods that are quick and painless.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Micropatch (microneedle patch)	Each micropatch contains an array of 50 microneedles.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-06-29
• Completion: 2022-06-29
• First posted: 2021-04-30
• Last updated: 2024-05-28
• Results posted: 2024-05-28

Locations

1 site across 1 country: United States