Healthy
Conditions
Keywords
Peer Reviewed Research
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.
Interventions
DEVICEMicropatch
Each micropatch contains 50 tiny projections (800 um in length)
Sponsors
University of Iowa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Micropore Re-sealing Kinetics | Four Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Trans-epidermal Water Loss | 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. |
| Skin Color Groups | 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\*. |
| Hydration | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Covid-19 Research Halt at University of Iowa-Withdrawal of subjects | 8 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Micropatch Application |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 46 Participants |
| Age, Continuous | 25.0 Years STANDARD_DEVIATION 6.9 |
| Race/Ethnicity, Customized African American/Black | 11 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants |
| Race/Ethnicity, Customized Bi-/Multiracial | 5 Participants |
| Race/Ethnicity, Customized Caucasian/White | 12 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 7 Participants |
| Race/Ethnicity, Customized Other-Pacific Islander | 1 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 46 |
| other Total, other adverse events | 3 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Micropore Re-sealing Kinetics
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.
Time frame: Four Days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micropatch Application | Micropore Re-sealing Kinetics | Forearm | 58.29 hours | Standard Deviation 16.76 |
| Micropatch Application | Micropore Re-sealing Kinetics | Upper arm | 60.34 hours | Standard Deviation 14.69 |
| Micropatch Application | Micropore Re-sealing Kinetics | Abdomen | 63.09 hours | Standard Deviation 13.13 |
Secondary
Change in Trans-epidermal Water Loss
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.
Time frame: Baseline (Day 0) and post micropatch application (Day 0)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micropatch Application | Change in Trans-epidermal Water Loss | Forearm | 243.96 percent change | Standard Deviation 126.33 |
| Micropatch Application | Change in Trans-epidermal Water Loss | Upper arm | 264.46 percent change | Standard Deviation 151.2 |
| Micropatch Application | Change in Trans-epidermal Water Loss | Abdomen | 225.47 percent change | Standard Deviation 137.67 |
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 5 sites at each body location.
Time frame: Baseline (Day 0)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Micropatch Application | Hydration | Forearm | 28.88 unitless | Standard Deviation 8.3 |
| Micropatch Application | Hydration | Upper arm | 28.02 unitless | Standard Deviation 8.94 |
| Micropatch Application | Hydration | Abdomen | 23.24 unitless | Standard Deviation 8.5 |
Secondary
Skin Color Groups
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\*.
Time frame: Baseline (Day 0)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Micropatch Application | Skin Color Groups | L* ≤ 50 | 10 Participants |
| Micropatch Application | Skin Color Groups | L* 51-65 | 9 Participants |
| Micropatch Application | Skin Color Groups | L* > 65 | 16 Participants |