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N/A N=46 Basic Science

Micropore Closure Kinetics at Various Body Sites

Healthy

Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcome: Primary: Micropore Re-sealing Kinetics — 58.29; 60.34; 63.09 hours

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Micropatch (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Iowa
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Micropore Re-sealing Kinetics
58.29; 60.34; 63.09
SECONDARY
Change in Trans-epidermal Water Loss
243.96; 264.46; 225.47
SECONDARY
Skin Color Groups
10; 9; 16
SECONDARY
Hydration
28.88; 28.02; 23.24

Summary

The study to be performed will define the rate of skin barrier recovery following micropatch application to the skin on the upper arm, volar forearm, and abdomen in healthy subjects.

Eligibility Criteria

Inclusion Criteria

  • 18 - 50 years of age
  • Healthy, non-obese men and women
  • Identify as African American or Black, Asian, Hispanic or Latino, Caucasian/White, bi-/multiracial or other

Exclusion Criteria

  • Unable to give consent
  • Severe general allergies requiring chronic treatment with steroids or antihistamines
  • Previous adverse reaction to micropatch application
  • Previous history of keloids
  • Known allergy or adverse reaction to medical tape/adhesive or aloe vera
  • Any inflammatory diseases of the skin; psoriasis, atopic dermatitis, and blistering skin disorders
  • Diseases associated with altered immune function (including but not limited to: rheumatoid arthritis, diabetes, lupus, HIV/AIDS)
  • Any subjects 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 micropatch application sites
  • Eczema or scaling present at the application sites
  • Any current inflammation or irritation present at the application sites (including but not limited to: rash, inflammation, erythema, edema, blisters)
  • BMI>29.9
  • Uncontrolled mental illness that would, in the opinion of the physician, 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, oral antibiotics, topical antibiotics at the micropatch application sites, topical antihistamines at the micropatch application sites, beta-blockers, and systemic or topical NSAIDS/analgesics/anti-inflammatories. A subject who has recently used oral or topical steroids, antibiotics, antihistamines, or analgesics may be enrolled if sufficient time has passed since the last dose (as determined by a member of the study team).
  • Any subjects that are pregnant/nursing will be excluded from participation.
  • Any condition that would, in the opinion of the study team, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03657277). 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.

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