Trial Outcomes & Findings for Visualizing Dermal Micropores With OCT (NCT NCT04867733)

NCT ID: NCT04867733

Last Updated: 2024-05-28

Results Overview

The depth of the micropore created at the upper arm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 49 participants
• Primary outcome timeframe: Post microneedle application (Day 0), approximately 5 minutes
• Results posted on: 2024-05-28

Participant Flow

Participant milestones

Measure	Micropatch Application All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visualizing Dermal Micropores With OCT

Baseline characteristics by cohort

Measure	Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.
Age, Continuous	26 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Post microneedle application (Day 0), approximately 5 minutes

The depth of the micropore created at the upper arm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Micropore Depth, Upper Arm

72.4 micrometer Standard Deviation 10.7

PRIMARY outcome

Timeframe: Post microneedle application (Day 0), approximately 5 minutes

The depth of the micropore created at the volar forearm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Micropore Depth, Volar Forearm

78.6 micrometer Standard Deviation 12.6

PRIMARY outcome

Timeframe: Post microneedle application (Day 0), approximately 5 minutes

The depth of the micropore created at the palm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Micropore Depth, Palm

102.8 micrometer Standard Deviation 21.2

SECONDARY outcome

Timeframe: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes

The percent change in trans-epidermal water loss from baseline to post-micropatch application at the upper arm sites will be calculated. 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. Data will be calculated as the mean of measurements from the micropatch sites at the upper arm.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Change in Trans-epidermal Water Loss, Upper Arm

267.4 percentage change from baseline Standard Deviation 95.8

SECONDARY outcome

Timeframe: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes

The percent change in trans-epidermal water loss from baseline to post-micropatch application at the volar forearm sites will be calculated. 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. Data will be calculated as the mean of measurements from the micropatch sites at the volar forearm.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Change in Trans-epidermal Water Loss, Volar Forearm

313.2 percentage change from baseline Standard Deviation 112.3

SECONDARY outcome

Timeframe: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes

The percent change in trans-epidermal water loss from baseline to post-micropatch application at the palm sites will be calculated. 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. Data will be calculated as the mean of measurements from the micropatch sites at the palm.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Change in Trans-epidermal Water Loss, Palm

131.3 percentage change from baseline Standard Deviation 46.1

SECONDARY outcome

Timeframe: Baseline (Day 0), <30 seconds

Lightness/darkness of the skin color is measured with a tristimulus colorimeter and reported in a unitless scale called the CIELAB color space (sometimes also called the L*a*b* color space). In this study we measured the value called L*. The L* values can range from 0 (black) to 100 (white). Higher L* values denote lighter skin, while lower L* values denote darker skin. The L* measurement is an objective measurement of skin color and there is no "better" or "worse" values of L*. The L* values are collected from the all 9 sites (3 each at upper arm, volar forearm, and palm) and the measurements are averaged together and reported as the mean.

Outcome measures

Measure

Micropatch Application n=49 Participants All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Skin Color

58.9 L* (unitless measure on a scale) Standard Deviation 8.6

Adverse Events

Micropatch Application

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Micropatch Application n=49 participants at risk All participants will complete this arm. Three sites each on the upper arm, volar (inner) forearm, and palm will be identified. Baseline measurements of trans-epidermal water loss, electrical resistance, and color will be made at each site. Baseline optical coherence tomography (OCT) scans will be made at each site. Color will only be measured at baseline. One site at each location will undergo the following interventions: 1) micropatch application and an occlusive covering, 2) micropatch application, but remain uncovered, 3) occlusive covering, no micropatch application. Micropatch application will only occur on the first day and does not contain any drug substance. Trans-epidermal water loss and electrical resistance are re-measured after micropatch removal, along with an additional OCT scan. Electrical resistance and OCT scans will be repeated at all sites for 2 days. Measurements from the 2nd and 3rd sites allow each subject to serve as their own control in data analysis. Micropatch (microneedle patch): Each micropatch contains an array of 50 microneedles.

Skin and subcutaneous tissue disorders Hyperpigmentation

6.1% 3/49 • Number of events 3 • Adverse events were monitored during the 3 days while a subject was completing the study and for three days after study completion.

Additional Information

Nicole Brogden

University of Iowa

Phone: 319-335-8752

Email: nicole-brogden@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place