Skin Barrier Function and Inflammation in Aging: The BIA Study

NCT06750653 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 21-34535R21AR082620
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Aging; Skin Inflammation

Keywords

CeraVe; Vaseline; Aging; Inflammation; Skin; Older Adults

Outcome Measures

Primary Outcomes (1)

• Demonstrate feasibility

  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.

  8 weeks

Secondary Outcomes (6)

• Change in composite inflammation score

  4 weeks

• Change in skin barrier function

  4 weeks

• Change in skin barrier function

  4 weeks

• Change in skin barrier function

  4 weeks

• Change in skin barrier function

  4 weeks

Study Arms (4)

CeraVe First

ACTIVE COMPARATOR

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.

Other: CeraVe Moisturizing Cream

CeraVe Second

ACTIVE COMPARATOR

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

Other: CeraVe Moisturizing Cream

Vaseline First

ACTIVE COMPARATOR

Vaseline for 4 weeks then no moisturizer for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use.

Drug: Vaseline

Vaseline Second

ACTIVE COMPARATOR

No moisturizer for 4 weeks; then Vaseline for 4 weeks. Vaseline white petrolatum, manufactured by Unilever, for topical skin use.

Drug: Vaseline

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.

CeraVe First; CeraVe Second

Vaseline DRUG

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

Vaseline First; Vaseline Second

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current infection.
• Open skin wounds.
• Physical limitations or lack of a caregiver preventing application of a moisturizer to skin on the trunk and extremities.
• Current use of topical medications, oral systemic immunomodulatory treatments, or anti-microbial treatments.
• Diagnosis of primary or acquired immunodeficiency.
• Use of skin moisturizer less than 1 week prior to enrollment visit, with the exception that participants may use non-study moisturizer/sunscreen on face, if used consistently throughout study period.
• Inability to give informed consent.
• Presence of a condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
• If the participant does not meet all the above criteria, he/she will not be eligible for study participation.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

Inflammation; Dermatitis

Interventions

Petrolatum

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Study Officials

• Katrina Abuabara, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Fernandez Lamothe

CONTACT

415-502-4739; ana.fernandezlamothe@ucsf.edu

Katrina Abuabara, MD

CONTACT

408-497-1553; katrina.abuabara@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Access to the randomization code will be strictly controlled. The moisturizing products will be placed in identical cardboard boxes by a staff member not involved in the disease assessments so that investigators taking assessments will not be aware of which study arm participants were randomized to. Participants will be asked not to open the cardboard packaging until they leave the study site.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will act as their own control - 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).

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: February 6, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be made available as soon as possible or at the time of associated publication. The duration of preservation and sharing of the data will be a minimum of 5 years after the end of the funding period. The investigators anticipate the IPD will be made available Starting October 1, 2026 through September 30, 2031.
• Access Criteria: The investigators will share individual participant level or IPD data. The data will be made available in a de-identified format. The investigators will also share the data dictionary, statistical analysis plan, analytic code, and final protocol with amendments. In order to maintain appropriate managed access of the data, the investigators will make it available via the Vivli platform. Vivli is a non-profit clinical research data sharing platform that has been created to meet the needs of researchers who use and produce clinical research data worldwide. Anyone who has submitted an approved data request and signed a data use agreement on Vivli will be given access to the data. In order to get access to the data, the user must submit a valid scientific question, include a statistical analysis plan, and complete all required fields on the Vivli data request form.

Locations

US (1)