Healthy Clinical Trial
Official title:
Evaluating Racial and Ethnic Differences in Dermal Micropore Formation Using Optical Coherence Tomography
Verified date | November 2022 |
Source | University of Iowa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds.
Status | Active, not recruiting |
Enrollment | 49 |
Est. completion date | April 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: Subjects will be healthy men and women between 18 and 45 years of age. Exclusion Criteria: 1. Unable to give consent 2. Severe general allergies requiring chronic treatment with steroid or antihistamines 3. Previous adverse reaction to microneedle insertion 4. History of keloids 5. Known allergy or adverse reaction to medical tape/adhesive, or aloe vera 6. Any inflammatory diseases of the skin (including but not limited to: psoriasis, atopic dermatitis, and blistering skin disorders) 7. Any disease associated with altered immune function (including but not limited to: rheumatoid arthritis, diabetes, lupus, HIV/AIDS) 8. Any subject taking medication that impairs the immune system (including but not limited to corticosteroids, TNF inhibitors, monoclonal antibodies, chemotherapy agents) 9. Any current malignancy or history of malignancy present at the treatment sites 10. Eczema or scaling present at any treatment site; any current inflammation or irritation present at the treatment sites (including but not limited to: rash, inflammation, erythema, edema, blisters) 11. Uncontrolled mental illness that would, in the opinion of the investigator, affect the subject's ability to understand or reliably participate in the study 12. Subjects taking medications in the following therapeutic classes will be excluded: HMGCoA reductase inhibitors ("statins"), oral or topical steroids (at the local treatment site), oral antibiotics, topical antibiotics at the local treatment site, topical antihistamines at the local treatment site, beta-blockers, and systemic or topical NSAIDS/analgesics. A subject who has recently used oral or topical steroids, antibiotics, antihistamines, or analgesics may be enrolled if more than 5 elimination half-lives of the drug have passed since the last dose (this is a typical parameter in pharmacokinetics, when it is assumed that ~97% of drug in the systemic circulation is eliminated after 5 half-lives). The estimated elimination half-life for any specific drug will be obtained from standard pharmacy references such as Micromedex or other comparable drug information references. 13. Any subjects that are pregnant/nursing will be excluded from participation. 14. Subjects will also be excluded for 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Iowa | Iowa City | Iowa |
Lead Sponsor | Collaborator |
---|---|
University of Iowa |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Micropore depth, upper arm | The depth of the micropore created at the upper arm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites. | Post microneedle application (Day 0) | |
Primary | Micropore depth, volar forearm | The depth of the micropore created at the volar forearm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites. | Post microneedle application (Day 0) | |
Primary | Micropore depth, palm | The depth of the micropore created at the palm will be measured using OCT scans. These data are only collected from the micropatch sites. Data will be calculated as the mean of micropore depth measured at all micropatch sites. | Post microneedle application (Day 0) | |
Secondary | Change in trans-epidermal water loss, upper arm | The percent change in trans-epidermal water loss from baseline to post-micropatch application at the upper arm sites will be calculated. These data are only collected from the micropatch sites. Percent change is calculated as (trans-epidermal water loss after micropatch application/baseline trans-epidermal water loss) x 100. Data will be calculated as the mean of measurements from the micropatch sites at the upper arm. | Baseline (Day 0) and post-microneedle application (Day 0) | |
Secondary | Change in trans-epidermal water loss, volar forearm | The percent change in trans-epidermal water loss from baseline to post-micropatch application at the volar forearm sites will be calculated. These data are only collected from the micropatch sites. Percent change is calculated as (trans-epidermal water loss after micropatch application/baseline trans-epidermal water loss) x 100. Data will be calculated as the mean of measurements from the micropatch sites at the volar forearm. | Baseline (Day 0) and post-microneedle application (Day 0) | |
Secondary | Change in trans-epidermal water loss, palm | The percent change in trans-epidermal water loss from baseline to post-micropatch application at the palm sites will be calculated. These data are only collected from the micropatch sites. Percent change is calculated as (trans-epidermal water loss after micropatch application/baseline trans-epidermal water loss) x 100. Data will be calculated as the mean of measurements from the micropatch sites at the palm. | Baseline (Day 0) and post-microneedle application (Day 0) | |
Secondary | Skin color | Lightness/darkness of the skin is measured with a tristimulus colorimeter and reported in a unitless value called L*. Higher L* values denote lighter skin, while lower L* values denote darker skin. Data are collected as the mean of measurements from the all 9 sites (3 each at upper arm, volar forearm, and palm). | Baseline (Day 0) |
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