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Micropore Closure Kinetics at Various Body Sites

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ClinicalTrials.gov Identifier: NCT03657277
Recruitment Status : Recruiting
First Posted : September 5, 2018
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Nicole K Brogden, University of Iowa

Tracking Information
First Submitted Date  ICMJE August 30, 2018
First Posted Date  ICMJE September 5, 2018
Last Update Posted Date October 23, 2019
Actual Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Micropore re-sealing kinetics [ Time Frame: Four Days ]
The time required for the skin barrier to be restored after micropatch application will be determined using electrical impedance measurements. Differences in the skin electrical impedance will be determined through measurements made with skin electrodes attached to an impedance meter.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03657277 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 21, 2019)
  • Trans-epidermal water loss [ Time Frame: One Day ]
    Differences in trans-epidermal water loss will be determined.
  • Skin color and redness [ Time Frame: Four Days ]
    Differences in skin color and redness will be determined.
  • Hydration [ Time Frame: Four Days ]
    Differences in skin hydration will be determined.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
  • Sebum Content [ Time Frame: Four Days ]
    Differences in skin sebum content will be determined.
  • Trans-epidermal water loss [ Time Frame: One Day ]
    Differences in trans-epidermal water loss will be determined.
  • Skin color and redness [ Time Frame: Four Days ]
    Differences in skin color and redness will be determined.
  • Hydration [ Time Frame: Four Days ]
    Differences in skin hydration will be determined.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Micropore Closure Kinetics at Various Body Sites
Official Title  ICMJE Characterizing Epidermal Responses Following Micropatch Application at Various Body Sites in Human Subjects of Diverse Racial/Ethnic Skin Types
Brief 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 of differing racial/ethnic backgrounds.
Detailed Description

Transdermal drug delivery (by way of patches that adhere to the skin and deliver drug in a time-dependent fashion) allows for systemic drug delivery through the skin, while avoiding many of the side effects and challenges associated with oral or intravenous drug delivery. One significant challenge limiting the number of drug compounds that can be transdermally delivered is the hydrophobic nature of the skin, which provides a barrier against absorption of drug molecules. Micropatches are a specialized type of patch that help drug molecules to cross the skin by creating micron-sized channels (also called micropores) in the skin, which makes the skin more permeable. Micropatches have been safely used in hundreds of patients for administration of drugs and vaccines through the skin. Studies have demonstrated that micropatch application is relatively painless and well-tolerated by most patients.

Following micropatch application, the skin must reseal the micropores in order to restore the skin's full barrier function. In young healthy individuals this process takes approximately 48 to 72 hours when the skin is covered by an occlusive patch. The timeframe is longer in older individuals who are >65 years of age. As evidenced by these age-related differences in restoration of skin barrier function, biological variation can have a significant effect on the skin's response after micropatch application. There are almost no data available regarding how race and ethnicity affect skin response to micropatch application. It is crucial to better understand how the rates of restoring barrier function vary in different racial/ethnic populations. This is very important for reducing potential for variability in drug delivery when new micropatches are developed in the future for treating diseases.

In this study researchers are examining skin characteristics and response to micropatch application, but there will be no drugs delivered in this study. Hydration and color will be measured to characterize the epidermal properties of individuals of different self-identified race and ethnicity. Measurements of trans-epidermal water loss and electrical impedance will be used to evaluate the formation of micropores in the skin; the electrical impedance measurements will be used to calculate the rate of barrier function repair. All of these skin characteristics can be measured using noninvasive methods that are quick and painless.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Device: Micropatch
Each micropatch contains 50 tiny projections (800 um in length)
Study Arms  ICMJE Micropatch Application
Five sites on each the upper arm, volar forearm, and abdomen will be identified, and baseline measurements of trans-epidermal water loss, electrical resistance, hydration, and color of the skin will be made at every site. At each body location, three of the sites will have a micropatch applied to the skin. The micropatches will then be discarded and the skin sites will be covered with an occlusive material secured in place with medical tape. The two remaining sites at each body location will not receive micropatch application, and one of these two sites will be covered with an occlusive material. Subjects will only receive micropatch application on the first day of the study. Measurements will be repeated daily at all sites for three consecutive days after the day of initial application (trans-epidermal water loss measurements will only be made on day 1).
Intervention: Device: Micropatch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 30, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jamie Carr 319-678-8089 brogden-lab@uiowa.edu
Contact: Nicole Brogden, PharmD, PhD nicole-brogden@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03657277
Other Study ID Numbers  ICMJE 201806039
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nicole K Brogden, University of Iowa
Study Sponsor  ICMJE University of Iowa
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicole Brogden, PharmD, PhD University of Iowa
PRS Account University of Iowa
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP