Micropore Closure Kinetics at Various Body Sites

NCT ID: NCT03657277

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2021-02-16

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Micropatch Application

This is the only study arm, which all participants complete. Five sites each on each the upper arm, forearm, and abdomen will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, hydration, and skin color will be made. Micropatches will be applied at three sites (at each body location). This only occurs on the first study day. Trans-epidermal water loss and electrical resistance are re-measured immediately after micropatch application. The sites will be covered with a small patch secured with medical tape. One site at each location will just be covered with a patch. The last site will not have micropatch application or patches. Electrical resistance will be re-measured at all sites for 3 days. Measurements from the 4th and 5th sites allow each subject to serve as their own control in data analysis.

Group Type: OTHER

Micropatch

Intervention Type: DEVICE

Each micropatch contains 50 tiny projections (800 um in length)

Interventions

Micropatch

Each micropatch contains 50 tiny projections (800 um in length)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 - 50 years of age
• Healthy, non-obese men and women
• Identify as African American or Black, Asian, Hispanic or Latino, Caucasian/White, bi-/multiracial or other

Exclusion Criteria

• Unable to give consent
• Severe general allergies requiring chronic treatment with steroids or antihistamines
• Previous adverse reaction to micropatch application
• Previous history of keloids
• Known allergy or adverse reaction to medical tape/adhesive or aloe vera
• Any inflammatory diseases of the skin; psoriasis, atopic dermatitis, and blistering skin disorders
• Diseases associated with altered immune function (including but not limited to: rheumatoid arthritis, diabetes, lupus, HIV/AIDS)
• Any subjects taking medication that impairs the immune system (including but not limited to corticosteroids, TNF inhibitors, monoclonal antibodies, chemotherapy agents)
• Any current malignancy or history of malignancy present at the micropatch application sites
• Eczema or scaling present at the application sites
• Any current inflammation or irritation present at the application sites (including but not limited to: rash, inflammation, erythema, edema, blisters)
• BMI>29.9
• Uncontrolled mental illness that would, in the opinion of the physician, affect the subject's ability to understand or reliably participate in the study
• Subjects taking medications in the following therapeutic classes will be excluded: HMGCoA reductase inhibitors ("statins"), oral or topical steroids, oral antibiotics, topical antibiotics at the micropatch application sites, topical antihistamines at the micropatch application sites, beta-blockers, and systemic or topical NSAIDS/analgesics/anti-inflammatories. A subject who has recently used oral or topical steroids, antibiotics, antihistamines, or analgesics may be enrolled if sufficient time has passed since the last dose (as determined by a member of the study team).
• Any subjects that are pregnant/nursing will be excluded from participation.
• Any condition that would, in the opinion of the study team, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Nicole K Brogden

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicole Brogden, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201806039

Identifier Type: -

Identifier Source: org_study_id