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Procedure

Micropatch (microneedle patch) for Healthy Subjects

N/A

Waitlist Available

Led By Nicole Brogden, PharmD, PhD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 0)

Awards & highlights

Study Summary

This trial will help researchers understand how well microneedles work on different skin types.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 0)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 0)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Micropore depth, palm

Micropore depth, upper arm

Micropore depth, volar forearm

Secondary outcome measures

Change in trans-epidermal water loss, palm

Change in trans-epidermal water loss, upper arm

Change in trans-epidermal water loss, volar forearm

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Micropatch applicationExperimental Treatment1 Intervention

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.

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Who is running the clinical trial?

University of IowaLead Sponsor

447 Previous Clinical Trials

879,673 Total Patients Enrolled

Nicole Brogden, PharmD, PhDPrincipal InvestigatorUniversity of Iowa

1 Previous Clinical Trials

46 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings remaining in this clinical examination?

"Based on clinicaltrials.gov, this investigation is no longer recruiting patients and was last modified on November 17th 2022. However, there are 843 other medical trials actively seeking participants at the present moment."

Answered by AI

Does this investigation permit seniors to participate?

"Eligible candidates for this clinical trial must be between 18 and 45 years old. There are a total of 50 trials open to minors, while 372 studies accept participants aged 65 or older."

Answered by AI

Who is eligible for participation in this study?

"49 participants who fit the following criteria are invited to participate in this study: healthy men and women aged 18-45. Inclusion Criteria: Subjects must be medically sound males and females aged between 18 and 45 years old."

Answered by AI

What tangible results is this experiment attempting to elicit?

"The primary measure of the clinical trial, occurring on Day 0 post-microneedle application, is Micropore depth in the upper arm. Secondary objectives include Skin color (assessed by tristimulus colorimeter and reported as L* values), Change in trans-epidermal water loss at volar forearm sites, and Change in trans-epidermal water loss at palm sites - all measured as mean values from nine different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Visualizing Dermal Micropores With OCT

Nicole K Brogden 2021. "Visualizing Dermal Micropores With OCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04867733.