Trial Outcomes & Findings for Micropore Closure Kinetics at Various Body Sites (NCT NCT03657277)
NCT ID: NCT03657277
Last Updated: 2021-07-28
Results Overview
The time required for the skin barrier to be restored after micropatch application at 3 sites on the body 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 re-sealing are only collected from the micropatch sites.
COMPLETED
NA
46 participants
Four Days
2021-07-28
Participant Flow
Recruitment on this study was open from October 2018 to March 2020. Study procedures were conducted at the University of Iowa Hospitals and Clinics in the Clinical Research Clinic by members of the research staff.
Subjects were screened after consenting to participate in the study. 2 of our 46 participants met exclusionary criteria after consenting. 1 of 46 participants signed the consent and stopped returning communication with study staff and was withdrawn from the study due to lack of follow-up. 8 of 46 were withdrawn from the study, prior to completing any visits, as a result of the closure of our clinical research unit due to the COVID-19 pandemic.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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46
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Overall Study
COMPLETED
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35
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Overall Study
NOT COMPLETED
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11
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Physician Decision
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2
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Overall Study
Lost to Follow-up
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1
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Overall Study
Covid-19 Research Halt at University of Iowa-Withdrawal of subjects
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8
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Baseline Characteristics
Micropore Closure Kinetics at Various Body Sites
Baseline characteristics by cohort
| Measure |
Micropatch Application
n=46 Participants
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.
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
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Age, Categorical
Between 18 and 65 years
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46 Participants
n=99 Participants
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
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Age, Continuous
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25.0 Years
STANDARD_DEVIATION 6.9 • n=99 Participants
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Sex: Female, Male
Female
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31 Participants
n=99 Participants
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Sex: Female, Male
Male
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15 Participants
n=99 Participants
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Race/Ethnicity, Customized
Hispanic/Latino
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7 Participants
n=99 Participants
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Race/Ethnicity, Customized
Caucasian/White
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12 Participants
n=99 Participants
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Race/Ethnicity, Customized
Asian
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10 Participants
n=99 Participants
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Race/Ethnicity, Customized
African American/Black
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11 Participants
n=99 Participants
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Race/Ethnicity, Customized
Other-Pacific Islander
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1 Participants
n=99 Participants
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Race/Ethnicity, Customized
Bi-/Multiracial
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5 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Four DaysThe time required for the skin barrier to be restored after micropatch application at 3 sites on the body 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 re-sealing are only collected from the micropatch sites.
Outcome measures
| Measure |
Micropatch Application
n=35 Participants
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.
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|---|---|
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Micropore Re-sealing Kinetics
Forearm
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58.29 hours
Standard Deviation 16.76
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Micropore Re-sealing Kinetics
Upper arm
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60.34 hours
Standard Deviation 14.69
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Micropore Re-sealing Kinetics
Abdomen
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63.09 hours
Standard Deviation 13.13
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SECONDARY outcome
Timeframe: Baseline (Day 0) and post micropatch application (Day 0)Percent change from baseline trans-epidermal water loss will be calculated after micropatch application at each body site, and these data are only collected from the micropatch sites. Percent change is calculated as (trans-epidermal water loss after micropatch application/baseline trans-epidermal water loss) x 100.
Outcome measures
| Measure |
Micropatch Application
n=35 Participants
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.
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|---|---|
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Change in Trans-epidermal Water Loss
Forearm
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243.96 percent change
Standard Deviation 126.33
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Change in Trans-epidermal Water Loss
Upper arm
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264.46 percent change
Standard Deviation 151.20
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Change in Trans-epidermal Water Loss
Abdomen
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225.47 percent change
Standard Deviation 137.67
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SECONDARY outcome
Timeframe: Baseline (Day 0)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 sites on the abdomen, and subjects are grouped into categories based on ranges of L\*.
Outcome measures
| Measure |
Micropatch Application
n=35 Participants
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.
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Skin Color Groups
L* ≤ 50
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10 Participants
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Skin Color Groups
L* 51-65
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9 Participants
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Skin Color Groups
L* > 65
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16 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 0)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 5 sites at each body location.
Outcome measures
| Measure |
Micropatch Application
n=35 Participants
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.
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|---|---|
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Hydration
Forearm
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28.88 unitless
Standard Deviation 8.3
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Hydration
Upper arm
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28.02 unitless
Standard Deviation 8.94
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Hydration
Abdomen
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23.24 unitless
Standard Deviation 8.5
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Adverse Events
Micropatch Application
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Micropatch Application
n=46 participants at risk
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.
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|---|---|
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Skin and subcutaneous tissue disorders
Skin redness or irritation
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6.5%
3/46 • Adverse Events were monitored at the micropatch sites during the 4 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place