Skin Barrier Function and Inflammation in Aging: The BIA Study (NCT06750653) | Clinical Trial Compass
RecruitingPhase 4
Skin Barrier Function and Inflammation in Aging: The BIA Study
United States32 participantsStarted 2025-02-06
Plain-language summary
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.
Who can participate
Age range70 Years
SexALL
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Inclusion criteria
✓. Male or female ≥ 70 years of age at the baseline visit.
✓. Diagnosis of xerosis cutis based on an Overall Dry skin (ODS) score of =\> 1 for any body site where patients will be asked to apply moisturizer (i.e. arms, legs, buttocks, front of trunk).
✓. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative
✓. Ability for subject to comply with the requirements of the study.
Exclusion criteria
✕. History of inflammatory skin disease (e.g. psoriasis, atopic dermatitis, or bullous pemphigoid) that has been active in the past 10 years.
✕. History of contact dermatitis to moisturizers.
✕. History of chronic inflammatory conditions (such as cancer, arthritis, inflammatory bowel disease, or coronary artery disease). Participants with a history of localized skin cancer will not be excluded.