Skin Barrier Function and Inflammation in Aging: The BIA Study

Phase 4

Recruiting

• Conditions: Inflammation; Skin Inflammation; Aging
• Interventions: Other: CeraVe Moisturizing Cream; Drug: Vaseline

• Registration Number: NCT06750653
• Lead Sponsor: University of California, San Francisco

Brief 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.

Detailed Description

In older adults, inflammation is associated with geriatric conditions, including multimorbidity and frailty, that result in premature death. This phenomenon has been termed 'inflammaging,' and multiple potential mechanisms have been identified, including chronic infections, visceral obesity, increased gut permeability, and cellular senescence, among others.1,2 Limited data suggest that age-associated barrier decline in the skin may also play an important role. Beginning at about age 50, skin barrier decline is caused by decreased Na+/H+ antiporter activity and impaired stratum corneum acidification.3 Persons \>70 years of age also suffer from additional defects in cutaneous lipid production.4 The result is reduced resilience to minor injury and epidermal cytokine generation, which may have significant systemic effects, given that the skin is the body's largest organ.5 Additionally, changes in the skin barrier may result in dysbiosis and increased exposure to microbial products, as has been seen in age-associated gut barrier decline.6 Skin barrier decline has been directly correlated with levels of keratinocyte-derived inflammatory markers in aged mice.7 Furthermore, there is experimental evidence that application of moisturizers to aged skin may improve skin barrier function and reduce inflammation. In aged mice, application of petrolatum twice daily for 10 days significantly reduced cutaneous and serum inflammatory cytokines including TNFalpha, IL-1alpha, IL-1beta, and IL-6 after minor injury.7 The investigators propose 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 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: placebo 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.

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-19
• Study First Posted: 2024-12-27
• Study Start: 2025-02-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CeraVe First	CeraVe Moisturizing Cream	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.
CeraVe Second	CeraVe Moisturizing Cream	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
Vaseline First	Vaseline	Vaseline for 4 weeks then no moisturizer for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use.
Vaseline Second	Vaseline	No moisturizer for 4 weeks; then Vaseline for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use.

Primary Outcome Measures

Name	Time	Method
Demonstrate feasibility	8 weeks	To demonstrate the feasibility of a moisturizer-based skin barrier enhancement randomized controlled trial using these measures: Enrollment Rate: Number of participants enrolled in the study within a specified time frame; Retention Rate: Percentage of participants who complete the study without dropping out, assessed at the end of the trial.; Adherence to Protocol: Percentage of participants who adhere to the treatment regimen as outlined, calculated based on participant self-reports or product usage logs.; Data Collection Completeness: Percentage of complete data sets collected for the primary outcome measure at baseline and follow-up.

Secondary Outcome Measures

Name	Time	Method
Change in composite inflammation score	4 weeks	Mean of the individual z-scores for serum inflammatory markers. Mean of the Individual Z-Scores for Serum Inflammatory Markers" assesses the standardized values (z-scores) of serum inflammatory markers in a population.; The normal range for z-scores is typically considered to be between: -2 and +2: This range typically encompasses about 95% of the data in a normally distributed population.; Outcome Interpretation: Higher z-scores indicate worse outcomes, as they suggest higher levels of inflammatory markers, which are typically associated with inflammation and various health issues.
Change in skin barrier function	4 weeks	Skin Electrical Impedance Spectroscopy Device: A specialized device designed for skin analysis that delivers a small-range alternating current to the skin surface and measures the voltage response to determine impedance.; Low Impedance Values: Generally indicate better skin hydration, as water facilitates increased conductivity.; High Impedance Values: Suggest lower hydration levels or impaired skin barrier function, as drier skin has reduced conductivity.
Measures of skin microbial composition diversity	4 weeks	Differences in overall microbiome composition after moisturizer application

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States