Skin Barrier Dysfunction and the Role of Skin Barrier Restoration
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | May 16, 2018 |
| End Date: | October 2019 |
| Contact: | Diane Fiolek |
| Email: | dianemch@umich.edu |
| Phone: | 734-763-1469 |
Skin Barrier Dysfunction and the Role of Skin Barrier Restoration on Cutaneous and Systemic Inflammation in the Aged Population
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.
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.
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.
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