Visualizing Dermal Micropores With OCT

NCT04867733 | Completed Results

• 1 other identifier: 2020010229
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Post microneedle application (Day 0), approximately 5 minutes

Secondary Outcomes (4)

• Change in Trans-epidermal Water Loss, Upper Arm

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

• Change in Trans-epidermal Water Loss, Volar Forearm

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

• Change in Trans-epidermal Water Loss, Palm

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

• Skin Color

  Baseline (Day 0), <30 seconds

Study Arms (1)

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.

Other: Micropatch (microneedle patch)

Interventions

Micropatch (microneedle patch) OTHER

Each micropatch contains an array of 50 microneedles.

Micropatch application

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

• 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.

  PMID: 40042738 DERIVED

Results Point of Contact

• Title: Nicole Brogden
• Organization: University of Iowa

nicole-brogden@uiowa.edu

319-335-8752

Study Officials

• Nicole Brogden, PharmD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: April 30, 2021
• Study Start: April 1, 2021
• Primary Completion: June 29, 2022
• Study Completion: June 29, 2022
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)