Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1
Completed NCT04052711 - A Randomized, Controlled Study to Evaluate the Sensitizing Potential of FMX-101 in Healthy Volunteers Using a Repeat Insult Patch Test Design Phase 1
Terminated NCT00001844 - Study of New Magnetic Resonance Methods
Completed NCT04319926 - Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Generic Lidocaine Patch 5% in Healthy, Adult, Human Subjects Phase 1
Completed NCT03160261 - Effect of Exenatide on Cortisol Secretion Phase 4
Completed NCT03662100 - A Study of Two Formulations of LY3074828 in Healthy Participants Phase 1
Recruiting NCT02875301 - Investigating Gains in Neurocognition in an Intervention Trial of Exercise Phase 3
Completed NCT01437592 - Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects Phase 1
Completed NCT03656952 - A Study to Evaluate the PF-06700841 Effect on QTc Interval in Healthy Volunteers Phase 1
Completed NCT03670082 - Study With Lu AF35700 in Healthy Men and Women in Fasting and Fed State Phase 1
Completed NCT03056846 - Probiotics on Stress-associated Gastrointestinal Function in University Students N/A
Completed NCT03203824 - The Effects of Dark Chocolate (70% Cacao) on EEG Brain Waves in Vigorously Active Individuals N/A