Actively Recruiting
Skin Barrier Function and Inflammation in Aging: The BIA Study
Led by University of California, San Francisco · Updated on 2026-03-06
32
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, investigator-blinded, self-controlled pilot study of the physiologic response to topical moisturizers among older adults with dry skin. The overarching hypothesis is that skin barrier decline is an important source of chronic inflammation, and that skin barrier restoration with moisturizers can reduce serum biomarkers of inflammation. The primary objective is to determine the feasibility for a larger trial, and the secondary objectives are to determine the extent to which measures of serum inflammation, skin barrier function, and the skin microbiome change in response to moisturizers. Participants will be asked to apply one of two topical moisturizers that are widely available over the counter in the US (Vaseline® 100% pure petroleum jelly or CeraVe® moisturizing cream) once daily for 4 weeks to the front of the torso, buttocks, arms, and legs. Subjects will act as their own control (i.e. they will be asked to apply the study moisturizer they are randomized to for one intervention period (4 weeks) and not to apply topical moisturizers for the other 4- week intervention period). Participants will be randomized in a 1:1:1:1 ratio to one of 4 treatment groups: i. no intervention then CeraVe; ii. CeraVe then no intervention; iii. no intervention then Vaseline; iv. Vaseline then no intervention. At each visit (baseline, week 4, and week 8), participants will undergo skin barrier testing, skin microbiome sampling, and phlebotomy to measure serum inflammatory markers.
CONDITIONS
Official Title
Skin Barrier Function and Inflammation in Aging: The BIA Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 70 years of age or older at the baseline visit
- Diagnosis of dry skin with an Overall Dry skin (ODS) score of 1 or higher on arms, legs, buttocks, or front trunk
- Written informed consent or assent obtained
- Ability to comply with study requirements
You will not qualify if you...
- History of active inflammatory skin diseases (psoriasis, atopic dermatitis, bullous pemphigoid) in the past 10 years
- History of contact dermatitis to moisturizers
- History of chronic inflammatory conditions like cancer, arthritis, inflammatory bowel disease, or coronary artery disease (except localized skin cancer)
- Current infection or open skin wounds
- Physical limitations or lack of caregiver preventing moisturizer application
- Current use of topical medications, oral immunomodulatory treatments, or antimicrobial treatments
- Diagnosis of primary or acquired immunodeficiency
- Use of skin moisturizer less than 1 week before enrollment (except consistent use of non-study moisturizer or sunscreen on face)
- Inability to give informed consent
- Any condition that may compromise safety or data quality as judged by the investigator
- Failure to meet all above criteria
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UCSF
San Francisco, California, United States, 94115
Actively Recruiting
Research Team
A
Ana Fernandez Lamothe
CONTACT
K
Katrina Abuabara, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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