Micropore Closure Kinetics at Various Body Sites

Completed · Not applicable

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT03657277

Run by

University of Iowa

People needed

46

Starts

2018-10-01

Expected to finish

2021-02-16

Last updated by the study team

2021-07-28

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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