Skin Barrier Function and Inflammation in Aging: The BIA Study

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06750653
Phase
PHASE4
Status
Recruiting
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Conditions

  • Aging
  • Inflammation
  • Skin Inflammation

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • CeraVe Moisturizing Cream — OTHER
    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.
  • Vaseline — DRUG
    Vaseline is a formulation of active ingredient white petrolatum, USP (100%), manufactured by Unilever, for topical skin use.

Study Details

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 Dates

Start date
Feb 6, 2025
Status verified
Mar 2026
Primary completion
Apr 15, 2026
Completion
Apr 15, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: CeraVe First
    CeraVe for 4 weeks; then no moisturizer for 4 weeks. CeraVe Moisturizing Cream containing ceramides and hyaluronic acid manufactured by L'Oréal, for topical skin use.
  • Active Comparator: CeraVe Second
    No moisturizer for 4 weeks, then CeraVe for the second 4-week study period. CeraVe Moisturizing Cream containing ceramides and hyaluronic acid manufactured by L'Oréal, for topical skin use
  • Active Comparator: Vaseline First
    Vaseline for 4 weeks then no moisturizer for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use.
  • Active Comparator: Vaseline Second
    No moisturizer for 4 weeks; then Vaseline for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use.

Primary Outcome Measure

Demonstrate feasibility [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94115
Ernesto Llamado
[email protected]

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