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RECRUITING
NCT06750653
PHASE4

Skin Barrier Function and Inflammation in Aging: The BIA Study

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2025-02-06

Completion Date

2026-04-15

Last Updated

2026-03-06

Healthy Volunteers

Yes

Interventions

OTHER

CeraVe Moisturizing Cream

CeraVe is a formulation of Purified Water, Glycerin, Cetareth-20 and Cetearyl Alcohol, Caprylic/Capric Triglyceride, Behentrimonium Methosulfate and Cetearyl Alcohol, Cetyl Alcohol, Petrolatum, Dimethicone, Hyaluronic Acid, Ceramide 1, Ceramide 3, Ceramide 6-II, Cholesterol, Phytosphingosine, Potassium Phosphate, Dipotassium phosphate, Phenoxyethanol, Methylparaben, Propylparaben, Disodium EDTA, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, manufactured by L'Oréal, for topical skin use.

DRUG

Vaseline

Vaseline is a formulation of active ingredient white petrolatum, USP (100%), manufactured by Unilever, for topical skin use.

Locations (1)

UCSF

San Francisco, California, United States