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Skin Barrier Function and Inflammation in Aging: The BIA Study

NCT06750653 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Katrina Abuabara, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2026-04-15
Completion
2026-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06750653 on ClinicalTrials.gov