Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT03332628
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03332628
Study Brief:
Protocol Section:
NCT03332628