Trial Outcomes & Findings for Racial/Ethnic Differences in Microneedle Response (NCT NCT03332628)

Last Updated: 2021-02-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

Five days

Results posted on

2021-02-15

Participant Flow

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.

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 Participants that did not meet screening criteria were withdrawn from the study, 5 of our 132 consented participants fell into this exclusionary criteria. 9 of 132 participants signed the consent and stopped returning communication with study staff prior to scheduling their appointments, they were withdrawn from the study due to lack of follow-up. 5 of 132 voluntarily withdrew consent because of schedule conflicts.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	113
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	2

Baseline Characteristics

Racial/Ethnic Differences in Microneedle Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microneedle Application n=111 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	25.9 Years STANDARD_DEVIATION 7.75 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Race/Ethnicity, Customized Asian	32 Participants n=5 Participants
Race/Ethnicity, Customized Bi-/Multi-racial	10 Participants n=5 Participants
Race/Ethnicity, Customized Black	22 Participants n=5 Participants
Race/Ethnicity, Customized White	23 Participants n=5 Participants
Race/Ethnicity, Customized Latino	23 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants
Region of Enrollment United States	111 Participants n=5 Participants

PRIMARY outcome

Timeframe: Five days

Population: 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.

Outcome measures

Outcome measures
Measure	Microneedle Application n=111 Participants This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. The 9 sites will be divided into 3 clusters of 3 sites each. Baseline measurements of hydration and color will be made at each site. The first site 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. Measurements of transepidermal water loss and impedance will be made before and after the microneedle treatments at these 3 sites. 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 measured daily for 4 consecutive days after microneedle application. 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.
Micropore Closure Time Asian	44.1 hours Standard Deviation 14.0
Micropore Closure Time Black	66.5 hours Standard Deviation 19.5
Micropore Closure Time White	50.1 hours Standard Deviation 12.4
Micropore Closure Time Latino	61.1 hours Standard Deviation 16.1
Micropore Closure Time Native American/Hawaiian	72 hours Standard Deviation 0
Micropore Closure Time Bi-/Multi-racial	48.0 hours Standard Deviation 16.0

SECONDARY outcome

Timeframe: Baseline (Day 0) and post microneedle application (Day 0)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Microneedle Application n=111 Participants This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. The 9 sites will be divided into 3 clusters of 3 sites each. Baseline measurements of hydration and color will be made at each site. The first site 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. Measurements of transepidermal water loss and impedance will be made before and after the microneedle treatments at these 3 sites. 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 measured daily for 4 consecutive days after microneedle application. 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.
Change in Trans-epidermal Water Loss Asians	212.81 Percantage change Standard Deviation 58.83
Change in Trans-epidermal Water Loss Bi-/Multi-racial	203.12 Percantage change Standard Deviation 79.81
Change in Trans-epidermal Water Loss Black	240.95 Percantage change Standard Deviation 97.47
Change in Trans-epidermal Water Loss White	228.25 Percantage change Standard Deviation 75.58
Change in Trans-epidermal Water Loss Latino	223.93 Percantage change Standard Deviation 82.31
Change in Trans-epidermal Water Loss Native American/Hawaiian	200 Percantage change Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline (Day 0)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Microneedle Application n=111 Participants This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. The 9 sites will be divided into 3 clusters of 3 sites each. Baseline measurements of hydration and color will be made at each site. The first site 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. Measurements of transepidermal water loss and impedance will be made before and after the microneedle treatments at these 3 sites. 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 measured daily for 4 consecutive days after microneedle application. 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.
Skin Color Black	40.61 Unitless Standard Deviation 6.74
Skin Color Asian	59.77 Unitless Standard Deviation 7.62
Skin Color Bi-/Multi-racial	61.12 Unitless Standard Deviation 5.79
Skin Color White	64.67 Unitless Standard Deviation 4.71
Skin Color Latino	58.84 Unitless Standard Deviation 7.21
Skin Color Native American/Hawaiian	60.37 Unitless Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline (Day 0)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Microneedle Application n=111 Participants This is the only arm of the study, which all participants complete. In each subject, 9 sites on the upper arm will be identified. The 9 sites will be divided into 3 clusters of 3 sites each. Baseline measurements of hydration and color will be made at each site. The first site 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. Measurements of transepidermal water loss and impedance will be made before and after the microneedle treatments at these 3 sites. 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 measured daily for 4 consecutive days after microneedle application. 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.
Hydration Asians	38.32 Unitless Standard Deviation 23.97
Hydration Bi-/Multi-racial	50.27 Unitless Standard Deviation 21.60
Hydration Black	34.75 Unitless Standard Deviation 18.49
Hydration White	36.06 Unitless Standard Deviation 18.81
Hydration Latino	35.61 Unitless Standard Deviation 14.23
Hydration Native American/Hawaiian	24.1 Unitless Standard Deviation 0

Adverse Events

Microneedle Application

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Microneedle Application n=113 participants at risk 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.
Skin and subcutaneous tissue disorders Mild Skin reaction to waterproof tape	0.88% 1/113 • 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.

Additional Information

Nicole Brogden, Associate Professor

University of Iowa

Phone: (319) 335-8752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place