Racial/Ethnic Differences in Microneedle Response (NCT03332628) | Clinical Trial Compass
CompletedNot Applicable
Racial/Ethnic Differences in Microneedle Response
United States132 participantsStarted 2018-02-01
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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
* Anyo…