Status:
COMPLETED
Racial/Ethnic Differences in Microneedle Response
Lead Sponsor:
University of Iowa
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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.
Detailed Description
Transdermal drug delivery (by way of patches that adhere to the skin and deliver drug in a time-dependent fashion) allows for systemic drug delivery through the skin, while avoiding many of the side e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2020
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03332628
Start Date
February 1 2018
End Date
October 13 2020
Last Update
February 15 2021
Active Locations (1)
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1
University of Iowa
Iowa City, Iowa, United States, 52242