Racial/Ethnic Differences in Microneedle Response

NCT03332628 | Completed Results

• 1 other identifier: 201708721
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The study to be performed will define the rate of skin barrier recovery following microneedle treatment of the skin in healthy subjects of differing racial/ethnic backgrounds.

Conditions

Healthy

Keywords

Peer Reviewed Research

Outcome Measures

Primary Outcomes (1)

• Micropore Closure Time

  The time required for the skin barrier to be restored after microneedle application 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 closure are only collected from the microneedle sites. Using the data collected from all 5 days an average micropore closure time will be calculated, which can be compared between subsets of participants based on race/ethnicity.

  Five days

Secondary Outcomes (3)

• Change in Trans-epidermal Water Loss

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

• Skin Color

  Baseline (Day 0)

• Hydration

  Baseline (Day 0)

Study Arms (1)

Microneedle application

OTHER

This is the only study arm, which all participants complete. Nine sites on the upper arm will be identified. Baseline measurements of transepidermal water loss, electrical resistance, hydration, and color will be made at each site. The 9 sites will be divided into clusters of 3 sites each. The first cluster will have small microneedle patches applied to at each site. This will only occur on the first study day. Transepidermal water loss and electrical resistance are re-measured immediately after microneedle application. The sites will be covered with a small patch secured with medical tape. The second cluster of sites will not receive microneedle application but will just be covered with patches. The last cluster of sites will not have microneedle application or patches. Electrical resistance will be re-measured at all sites for 4 days after microneedle application. Measurements from the 2nd and 3rd cluster of sites allow each subject to serve as their own control in data analysis.

Device: Microneedle patch

Interventions

Microneedle patch DEVICE

Each patch contains 50 microneedles.

Microneedle application

Eligibility Criteria

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

You may qualify if:

• Subjects will be healthy men and women between 18 - 50 years of age who identify as African American or Black, Asian, Hispanic or Latino, American Indian/Alaska Native, Native Hawaiian/Other Pacific Islander, Caucasian/White, bi-/multiracial.

You may not qualify if:

• Unable to give consent
• Severe general allergies requiring chronic treatment with steroids or antihistamines
• Previous adverse reaction to microneedle insertion
• Known allergy or adverse reaction to medical tape, adhesive, or aloe vera
• Anyone with inflammatory diseases of the skin or diseases that alter immune function
• Anyone taking any medications that impair the immune system will be excluded (contraceptives, vitamins, and topical products on the face will be allowed)
• Anyone with current malignancy or history of malignancy present at the treatment site (upper arm)
• Anyone with any of the following present at the treatment site (upper arm): eczema or scaling, inflammation, erythema, edema, blisters
• Anyone with uncontrolled mental illness that would, in the opinion of the physician, affect their ability to understand or reliably participate in the study
• Anyone taking medications in the following therapeutic classes will be excluded: HMGCoA reductase inhibitors ("statins"), oral or topical steroids, oral antibiotics, topical antibiotics at the local treatment site, topical antihistamines at the local treatment site, beta-blockers, and systemic or topical NSAIDS/analgesics
• Anyone who is pregnant or nursing
• Anyone with 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

Results Point of Contact

• Title: Nicole Brogden, Associate Professor
• Organization: University of Iowa

nicole-brogden@uiowa.ed

(319) 335-8752

Study Officials

• Nicole K Brogden, PharmD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• 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: October 30, 2017
• First Posted: November 6, 2017
• Study Start: February 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: October 13, 2020
• Last Updated: February 15, 2021
• Results First Posted: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)