N/A
N=49
Visualizing Dermal Micropores With OCT
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04867733 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Micropore Depth, Upper Arm — 72.4 micrometer
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Micropatch (microneedle patch) (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Micropore Depth, Upper Arm |
72.4 | — |
| PRIMARY Micropore Depth, Volar Forearm |
78.6 | — |
| PRIMARY Micropore Depth, Palm |
102.8 | — |
| SECONDARY Change in Trans-epidermal Water Loss, Upper Arm |
267.4 | — |
| SECONDARY Change in Trans-epidermal Water Loss, Volar Forearm |
313.2 | — |
| SECONDARY Change in Trans-epidermal Water Loss, Palm |
131.3 | — |
| SECONDARY Skin Color |
58.9 | — |
Summary
The study to be performed will allow visualization of skin micropores following microneedle treatment in healthy subjects in differing racial/ethnic backgrounds.
Eligibility Criteria
Inclusion Criteria: Subjects will be healthy men and women between 18 and 45 years of age.
Exclusion Criteria
- Unable to give consent
- Severe general allergies requiring chronic treatment with steroid or antihistamines
- Previous adverse reaction to microneedle insertion
- History of keloids
- Known allergy or adverse reaction to medical tape/adhesive, or aloe vera
- Any inflammatory diseases of the skin (including but not limited to: psoriasis, atopic dermatitis, and blistering skin disorders)
- Any disease associated with altered immune function (including but not limited to: rheumatoid arthritis, diabetes, lupus, HIV/AIDS)
- Any subject taking medication that impairs the immune system (including but not limited to corticosteroids, TNF inhibitors, monoclonal antibodies, chemotherapy agents)
- Any current malignancy or history of malignancy present at the treatment sites
- 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)
- Uncontrolled mental illness that would, in the opinion of the investigator, affect the subject's ability to understand or reliably participate in the study
- 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.
- Any subjects that are pregnant/nursing will be excluded from participation.
- 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.
Data sourced from ClinicalTrials.gov (NCT04867733). 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.