Micropore Closure Kinetics at Various Body Sites
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|ClinicalTrials.gov Identifier: NCT03657277|
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Device: Micropatch||Not Applicable|
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, color, and sebum content 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Characterizing Epidermal Responses Following Micropatch Application at Various Body Sites in Human Subjects of Diverse Racial/Ethnic Skin Types|
|Actual Study Start Date :||October 1, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Five sites on each the upper arm, volar forearm, and abdomen will be identified, and baseline measurements of trans-epidermal water loss, electrical resistance, sebum content, hydration, and color of the skin will be made at every site. At each body location, three of the sites will have a micropatch applied to the skin. The micropatches will then be discarded and the skin sites will be covered with an occlusive material secured in place with medical tape. The two remaining sites at each body location will not receive micropatch application, and one of these two sites will be covered with an occlusive material. Subjects will only receive micropatch application on the first day of the study. Measurements will be repeated daily at all sites for three consecutive days after the day of initial application (trans-epidermal water loss measurements will only be made on day 1).
Each micropatch contains 50 tiny projections (800 um in length)
- Micropore re-sealing kinetics [ Time Frame: Four Days ]The time required for the skin barrier to be restored after micropatch application will be determined using electrical impedance measurements. Differences in the skin electrical impedance will be determined through measurements made with skin electrodes attached to an impedance meter.
- Sebum Content [ Time Frame: Four Days ]Differences in skin sebum content will be determined.
- Trans-epidermal water loss [ Time Frame: One Day ]Differences in trans-epidermal water loss will be determined.
- Skin color and redness [ Time Frame: Four Days ]Differences in skin color and redness will be determined.
- Hydration [ Time Frame: Four Days ]Differences in skin hydration will be determined.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657277
|Contact: Jamie Carrfirstname.lastname@example.org|
|Contact: Nicole Brogden, PharmD, PhDemail@example.com|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Nicole K. Brogden, PharmD, PhD 319-335-8752 firstname.lastname@example.org|
|Principal Investigator:||Nicole Brogden, PharmD, PhD||University of Iowa|