Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-24 @ 10:53 PM
NCT ID:
NCT03728569
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03728569
Study Brief:
Protocol Section:
NCT03728569