N/A
N=113
Racial/Ethnic Differences in Microneedle Response
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03332628 ↗Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Micropore Closure Time — 44.1; 48.0; 66.5; 50.1 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microneedle patch (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Micropore Closure Time |
44.1; 48.0; 66.5; 50.1; 61.1; 72 | — |
| SECONDARY Change in Trans-epidermal Water Loss |
212.81; 203.12; 240.95; 228.25; 223.93; 200 | — |
| SECONDARY Skin Color |
40.61; 59.77; 61.12; 64.67; 58.84; 60.37 | — |
| SECONDARY Hydration |
38.32; 50.27; 34.75; 36.06; 35.61; 24.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03332628). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.