Clinical trial NCT03728569: Skin Barrier Dysfunction and the Role of Skin Barrier Restoration
Official title: Skin Barrier Dysfunction and the Role of Skin Barrier Restoration on Cutaneous and Systemic Inflammation in the Aged Population
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Cutaneous Inflammation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Both groups, young and old, will receive the same intervention; therefore, single group study model was chosen.
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this exploratory study is to gain an understanding of cutaneous and systemic inflammation and how restoration of the skin barrier through the use of moisturizer may restore the skin barrier function and reduce systemic inflammation in elderly humans compared to the young. The exploratory study will consist of three visits per subject. Subjects will be instructed to apply a moisturizer (Vanicream Moisturizing Skin Cream) over the entire skin surface from the neck down twice daily for up to 30 days.


Eligibility criteria: Inclusion Criteria:

Aged group (\>70 years old)

* In good general health
* Body mass index (BMI) preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
* Fitzpatrick skin types I-V
* Disrupted skin barrier defined as transepidermal water loss (TEWL) \>5 g/m2/h on the upper arms or \>3 g/m2/h on the buttocks
* Clinical signs of skin dryness as determined by the investigator.
* No disease states or physical conditions that would impair evaluation of the biopsy sites
* Signed, written and witnessed informed consent form
* Willing to comply with study procedures

Young group (18-30 years old)

* Good general health
* BMI preferably in the healthy range (approximately 25 kg/m2) and no greater than 30 kg/m2
* Fitzpatrick skin types I-V
* Disrupted skin barrier defined as transepidermal water loss (TEWL) \>5 g/m2/h on the upper arms or \>3 g/m2/h on the buttocks
* Clinical signs of skin dryness as determined by the investigator
* No disease states or physical conditions that would impair evaluation of the biopsy sites
* Signed, written and witnessed informed consent form
* Willing to comply with study procedures

Exclusion Criteria:

* Pregnant or lactating women or women contemplating pregnancy for the duration of the protocol (determined by self-report; if subjects are unsure of their pregnancy status, they will be excluded).
* Frailty as determined by research study nurse
* History of inflammatory skin conditions such as psoriasis or atopic dermatitis.
* History of uncontrolled inflammatory or autoimmune disease.
* History of keloids or any other condition that would complicate wound healing
* History of allergic reactions to local lidocaine
* Frequent nonsteroidal anti-inflammatory drug (NSAID) use (not including low dose aspirin) and unwilling/unable to discontinue NSAIDS for 2 weeks prior to enrollment to the end of the study.
* Systemic steroids (excluding inhaled steroids for asthma) and unwilling/unable to discontinue systemic steroids for 3 weeks prior to enrollment to the end of the study.
* Topical corticosteroid use within 2 weeks of enrollment.
* Topical immunomodulation use such as calcineurin inhibitors within 2 weeks of enrollment
* Other anti-inflammatory or immunodulatory medications (immunosuppression)
* Received an experimental drug or used an experimental device 30 days prior to admission to the study.

Primary outcomes:
measure: Change in skin hydration status in aged and young subjects
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Gary Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
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