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The study to be performed will define the rate of skin barrier recovery following microneedle treatment of the skin in healthy subjects of differing racial/ethnic backgrounds.
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. Microneedles are a minimally invasive means of allowing drug molecules to cross the skin by creating micron-sized channels (also called micropores) in the skin, thereby increasing its permeability. Microneedles have been safely used in hundreds of patients for administration of drugs and vaccines through the skin. Studies have demonstrated that microneedle treatment is relatively painless and well-tolerated by most patients.
Following microneedle treatment, the skin must heal the micropores in order to restore 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 for micropore closure is longer in elderly individuals (>65 years of age), taking several days longer to restore the skin barrier. As evidenced by the differences in micropore closure rate observed with advancing age, biological variation can have a significant effect on the skin's healing properties. There are almost no data available regarding how race and ethnicity affect skin response to microneedle insertion. It is crucial to better understand how the rates of micropore closure vary in different racial/ethnic populations because the potential for variability in drug delivery is high if the recovery timeframes are poorly understood.
In this study we will measure hydration and color 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 micropore closure. All of these skin characteristics can be measured using noninvasive methods that are quick and painless.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Microneedle application | Other | This is the only study arm, which all participants complete. Nine sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day. Transepidermal water loss and electrical resistance are re-measured immediately after microneedle application. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured at all sites for 4 days after microneedle application. Measurements from the 2nd and 3rd cluster of sites allow each subject to serve as their own control in data analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle patch | Device | Each patch contains 50 microneedles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Micropore Closure Time | The time required for the skin barrier to be restored after microneedle application will be determined using electrical resistance measurements. Differences in the skin electrical resistance will be determined through measurements made every day with skin electrodes attached to an impedance meter. These data for micropore closure are only collected from the microneedle sites. Using the data collected from all 5 days an average micropore closure time will be calculated, which can be compared between subsets of participants based on race/ethnicity. | Five days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Trans-epidermal Water Loss | Percent change from baseline trans-epidermal water loss will be calculated after microneedle application, and these data are only collected from the microneedle sites. Percent change is calculated as (trans-epidermal water loss after microneedle application/baseline trans-epidermal water loss) x 100. | Baseline (Day 0) and post microneedle application (Day 0) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole K Brogden, PharmD, PhD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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Subjects were screened after consenting to participate in the study. Participants that did not meet screening criteria were withdrawn from the study, 5 of our 132 consented participants fell into this exclusionary criteria. 9 of 132 participants signed the consent and stopped returning communication with study staff prior to scheduling their appointments, they were withdrawn from the study due to lack of follow-up. 5 of 132 voluntarily withdrew consent because of schedule conflicts.
Recruitment on this study was open from January 2018 to November 2019. Study procedures were conducted at the University of Iowa Hospitals and Clinics in the Clinical Research Clinic by members of the research staff.
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| ID | Title | Description |
|---|---|---|
| FG000 | Microneedle Application | This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis. Microneedle patch: Each patch contains 50 microneedles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Microneedle Application | This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis. Microneedle patch: Each patch contains 50 microneedles. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Micropore Closure Time | The time required for the skin barrier to be restored after microneedle application will be determined using electrical resistance measurements. Differences in the skin electrical resistance will be determined through measurements made every day with skin electrodes attached to an impedance meter. These data for micropore closure are only collected from the microneedle sites. Using the data collected from all 5 days an average micropore closure time will be calculated, which can be compared between subsets of participants based on race/ethnicity. | Data from all 111 participants was analyzed. The number in each row differs from the overall number because results are reported according to racial and ethnic subgroups. | Posted | Mean | Standard Deviation | hours | Five days |
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Adverse Events were monitored during the 5 days while a subject was completing the study and for three days after study completion.
Through the course of this study adverse events were recorded as reported from the subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microneedle Application | This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into 3 clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day, and the microneedle patches will then be discarded. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured daily at all sites for 4 consecutive days after microneedle application. The measurements from the second and third cluster of sites allow each subject to serve as their own control in data analysis. Microneedle patch: Each patch contains 50 microneedles. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Skin reaction to waterproof tape | Skin and subcutaneous tissue disorders | Non-systematic Assessment | One subject discontinued the study early due to a mild skin reaction to the waterproof medical tape used to secure the occlusive patches on the skin (this subject's data was not included in the analysis) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole Brogden, Associate Professor | University of Iowa | (319) 335-8752 | nicole-brogden@uiowa.ed |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 29, 2020 | Dec 1, 2020 | Prot_SAP_000.pdf |
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| Skin Color | Lightness/darkness of the skin is measured with a tristimulus colorimeter and reported in a unitless value called L*. Higher L* values denote lighter skin, while lower L* values denote darker skin. Data are calculated as the mean of measurements from all 9 sites on the arm. | Baseline (Day 0) |
| Hydration | Baseline skin hydration will be measured using a capacitance probe. The software calculates arbitrary unitless values. Values less than 30 are considered very dry while values over 40 are considered sufficiently moisturized. Data are calculated as the mean of measurements from all 9 sites on the arm. | Baseline (Day 0) |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Change in Trans-epidermal Water Loss | Percent change from baseline trans-epidermal water loss will be calculated after microneedle application, and these data are only collected from the microneedle sites. Percent change is calculated as (trans-epidermal water loss after microneedle application/baseline trans-epidermal water loss) x 100. | Data from all 111 participants was analyzed. The number in each row differs from the overall number because results are reported according to racial and ethnic subgroups. | Posted | Mean | Standard Deviation | Percantage change | Baseline (Day 0) and post microneedle application (Day 0) |
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| Secondary | Skin Color | Lightness/darkness of the skin is measured with a tristimulus colorimeter and reported in a unitless value called L*. Higher L* values denote lighter skin, while lower L* values denote darker skin. Data are calculated as the mean of measurements from all 9 sites on the arm. | Data from all 111 participants was analyzed. Data are calculated as the mean of measurements from all 9 sites on the arm. The number in each row differs from the overall number because results are reported according to racial and ethnic subgroups. Results are presented as prespecified in the protocol to collect and analyze data for all subjects together by ethnicity/race. | Posted | Mean | Standard Deviation | Unitless | Baseline (Day 0) |
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| Secondary | Hydration | Baseline skin hydration will be measured using a capacitance probe. The software calculates arbitrary unitless values. Values less than 30 are considered very dry while values over 40 are considered sufficiently moisturized. Data are calculated as the mean of measurements from all 9 sites on the arm. | Data from all 111 participants was analyzed. The number in each row differs from the overall number because results are reported according to racial and ethnic subgroups. Data are calculated as the mean of measurements from all 9 sites on the arm. Results are presented as prespecified in the protocol to collect and analyze data for all subjects together by ethnicity/race. | Posted | Mean | Standard Deviation | Unitless | Baseline (Day 0) |
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| 0 |
| 113 |
| 0 |
| 113 |
| 1 |
| 113 |
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| White |
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| Latino |
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| Native American/Hawaiian |
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| Bi-/Multi-racial |
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| White |
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| Latino |
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| Native American/Hawaiian |
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| Black |
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| White |
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| Latino |
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| Native American/Hawaiian |
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