HealthyNCT04867733
Visualizing Dermal Micropores With OCT
A study testing Micropatch (microneedle patch) in people with Healthy, run by University of Iowa at 1 site in United States.
Trial summary
The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Micropatch (microneedle patch)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 29 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Unable to give consent
- Severe general allergies requiring chronic treatment with steroid or antihistamines
- Previous adverse reaction to microneedle insertion
- History of keloids
- Known allergy or adverse reaction to medical tape/adhesive, or aloe vera
- Any inflammatory diseases of the skin (including but not limited to: psoriasis, atopic dermatitis, and blistering skin disorders)
Show all 14Show fewer
- Any disease associated with altered immune function (including but not limited to: rheumatoid arthritis, diabetes, lupus, HIV/AIDS)
- Any subject 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 treatment sites
- Eczema or scaling present at any treatment site; any current inflammation or irritation present at the treatment sites (including but not limited to: rash, inflammation, erythema, edema, blisters)
- Uncontrolled mental illness that would, in the opinion of the investigator, 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 (at the local treatment site), oral antibiotics, topical antibiotics at the local treatment site, topical antihistamines at the local treatment site, beta-blockers, and systemic or topical NSAIDS/analgesics. A subject who has recently used oral or topical steroids, antibiotics, antihistamines, or analgesics may be enrolled if more than 5 elimination half-lives of the drug have passed since the last dose (this is a typical parameter in pharmacokinetics, when it is assumed that ~97% of drug in the systemic circulation is eliminated after 5 half-lives). The estimated elimination half-life for any specific drug will be obtained from standard pharmacy references such as Micromedex or other comparable drug information references.
- Any subjects that are pregnant/nursing will be excluded from participation.
- Subjects will also be excluded for any condition that would, in the opinion of the PI or physician, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Racial and Ethnic Differences in Dermal Micropore Formation Using Optical Coherence Tomography
The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds.
Read the 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 highly efficient barrier against the absorption of drug molecules. Micropatches are small patches with tiny projections that are a minimally invasive way to allow drug molecules to cross the skin by creating micron-sized channels (also called micropores) in the skin, thereby increasing its permeability. Micropatches have been safely used in hundreds of patients for administration of drugs and vaccines through the skin. Studies have demonstrated that micropatch treatment is relatively painless and well-tolerated by most patients.
Following micropatch treatment, the skin must heal the micropores. In young healthy individuals this process takes approximately 48 to 72 hours when the skin is covered by an occlusive patch. One of the factors that may also affect micropore healing time is the depth of the micropores in the skin immediately after micropatch treatment. There are almost no data available regarding how race and ethnicity affect the depth of micropores after micropatch application. It is important to study differences in micropore depth so investigators can better understand why rates of micropore closure vary in different racial/ethnic populations. Without this information the potential for variability in drug delivery is high.
In this study the investigators will objectively measure skin color with a colorimeter to characterize the epidermal properties of individuals of different self-identified races and ethnicities. Measurements of trans-epidermal water loss will be used to evaluate formation of micropores in the skin; electrical impedance measurements will be used to estimate rates of micropore closure. The investigators will visualize the micropores created after micropatch treatment with the use of an optical coherence tomography instrument that will allow for calculation of epidermal thickness and micropore depth. All of these skin characteristics can be measured using noninvasive methods that are quick and painless.
- Conditions
- Healthy
- Being tested
- Micropatch (microneedle patch)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropatch (microneedle patch)Other
Each micropatch contains an array of 50 microneedles.
| Study group | Role | What they receive |
|---|---|---|
| Micropatch application | Experimental | 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. Receives: Other: Micropatch (microneedle patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Micropore Depth, Upper Arm
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.
Measured: Post microneedle application (Day 0), approximately 5 minutes
Micropore Depth, Volar Forearm
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.
Measured: Post microneedle application (Day 0), approximately 5 minutes
Micropore Depth, Palm
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.
Measured: Post microneedle application (Day 0), approximately 5 minutes
Secondary outcomes (4)
Change in Trans-epidermal Water Loss, Upper Arm
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.
Measured: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes
Change in Trans-epidermal Water Loss, Volar Forearm
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.
Measured: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes
Change in Trans-epidermal Water Loss, Palm
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.
Measured: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes
Skin Color
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.
Measured: Baseline (Day 0), <30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Apr 2021
- Primary completion29 Jun 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole K Brogden, University of Iowa
- Investigators
- Nicole Brogden, PharmD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867733
- Sponsor's protocol ID
- 2020010229
- Status last verified
- Dec 2023
- First submitted
- 29 Apr 2021
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cota V, Brogden NK. Micropore visualization and lifetime following microneedle application to skin of differing pigments. Drug Deliv Transl Res. 2025 Oct;15(10):3528-3541. doi: 10.1007/s13346-025-01817-9. Epub 2025 Mar 5.
PubMed 40042738
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Racial and Ethnic Differences in Dermal Micropore Formation Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04867733
- Acronym / sponsor ID
- 2020010229
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 29 Jun 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds.
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 highly efficient barrier against the absorption of drug molecules. Micropatches are small patches with tiny projections that are a minimally invasive way to allow drug molecules to cross the skin by creating micron-sized channels (also called micropores) in the skin, thereby increasing its permeability. Micropatches have been safely used in hundreds of patients for administration of drugs and vaccines through the skin. Studies have demonstrated that micropatch treatment is relatively painless and well-tolerated by most patients.
Following micropatch treatment, the skin must heal the micropores. In young healthy individuals this process takes approximately 48 to 72 hours when the skin is covered by an occlusive patch. One of the factors that may also affect micropore healing time is the depth of the micropores in the skin immediately after micropatch treatment. There are almost no data available regarding how race and ethnicity affect the depth of micropores after micropatch application. It is important to study differences in micropore depth so investigators can better understand why rates of micropore closure vary in different racial/ethnic populations. Without this information the potential for variability in drug delivery is high.
In this study the investigators will objectively measure skin color with a colorimeter to characterize the epidermal properties of individuals of different self-identified races and ethnicities. Measurements of trans-epidermal water loss will be used to evaluate formation of micropores in the skin; electrical impedance measurements will be used to estimate rates of micropore closure. The investigators will visualize the micropores created after micropatch treatment with the use of an optical coherence tomography instrument that will allow for calculation of epidermal thickness and micropore depth. All of these skin characteristics can be measured using noninvasive methods that are quick and painless.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micropatch application | Experimental | Other: Micropatch (microneedle patch)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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Unable to give consent
- Severe general allergies requiring chronic treatment with steroid or antihistamines
- Previous adverse reaction to microneedle insertion
- History of keloids
- Known allergy or adverse reaction to medical tape/adhesive, or aloe vera
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micropatch (microneedle patch)Each micropatch contains an array of 50 microneedles. | Other | Micropatch application |
Primary outcome
Micropore Depth, Upper Arm
Time frame: 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.
Micropore Depth, Volar Forearm
Time frame: 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.
Micropore Depth, Palm
Time frame: 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.
4 secondary outcomes
Change in Trans-epidermal Water Loss, Upper Arm
Time frame: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes
Change in Trans-epidermal Water Loss, Volar Forearm
Time frame: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes
Change in Trans-epidermal Water Loss, Palm
Time frame: Baseline (Day 0) and post-microneedle application (Day 0), approximately 1-3 minutes
Skin Color
Time frame: Baseline (Day 0), <30 seconds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40042738Cota V, Brogden NK. Micropore visualization and lifetime following microneedle application to skin of differing pigments. Drug Deliv Transl Res. 2025 Oct;15(10):3528-3541. doi: 10.1007/s13346-025-01817-9. Epub 2025 Mar 5.
- Individual participant dataSharing planned: No
Related trials for Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
RecruitingPhase 1
A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body
Healthy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Brogden, PharmD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropatch (microneedle patch) in people with Healthy, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micropore Depth, Upper Arm (time frame: Post microneedle application (Day 0), approximately 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04867733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.