Micropore Closure Kinetics at Various Body Sites

NCT03657277 | Completed Results

• 1 other identifier: 201806039
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Peer Reviewed Research

Outcome Measures

Primary Outcomes (1)

• 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.

  Four Days

Secondary Outcomes (3)

• Change in Trans-epidermal Water Loss

  Baseline (Day 0) and post micropatch application (Day 0)

• Skin Color Groups

  Baseline (Day 0)

• Hydration

  Baseline (Day 0)

Study Arms (1)

Micropatch Application

OTHER

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.

Device: Micropatch

Interventions

Micropatch DEVICE

Each micropatch contains 50 tiny projections (800 um in length)

Micropatch Application

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Results Point of Contact

• Title: Nicole Brogden
• Organization: University of Iowa

nicole-brogden@uiowa.edu

3193358752

Study Officials

• Nicole Brogden, PharmD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: August 30, 2018
• First Posted: September 5, 2018
• Study Start: October 1, 2018
• Primary Completion: March 18, 2020
• Study Completion: February 16, 2021
• Last Updated: July 28, 2021
• Results First Posted: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)