Skin Barrier Dysfunction and the Role of Skin Barrier Restoration

This is an interventional basic science trial for Cutaneous Inflammation Read More

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.