NCT06750653 Skin Barrier Function and Inflammation in Aging: The BIA Study
| NCT ID | NCT06750653 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Inflammation |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2026-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 32 participants in total. It began in 2025-02-06 with a primary completion date of 2026-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria 1. Male or female ≥ 70 years of age at the baseline visit. 2. 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). 3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative 4. Ability for subject to comply with the requirements of the study. Exclusion Criteria 1. History of inflammatory skin disease (e.g. psoriasis, atopic dermatitis, or bullous pemphigoid) that has been active in the past 10 years. 2. History of contact dermatitis to moisturizers. 3. 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. 4. Current infection. 5. Open skin wounds. 6. Physical limitations or lack of a caregiver preventing application of a moisturizer to skin on the trunk and extremities. 7. Current use of topical medications, oral systemic immunomodulatory treatments, or anti-microbial treatments. 8. Diagnosis of primary or acquired immunodeficiency. 9. 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. 10. Inability to give informed consent. 11. 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. 12. If the participant does not meet all the above criteria, he/she will not be eligible for study participation.
Contact & Investigator
Katrina Abuabara, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06750653 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Inflammation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06750653 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06750653 currently recruiting?
Yes, NCT06750653 is actively recruiting participants. Contact the research team at ana.fernandezlamothe@ucsf.edu for enrollment information.
Where is the NCT06750653 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06750653 clinical trial?
NCT06750653 is sponsored by University of California, San Francisco. The principal investigator is Katrina Abuabara, MD at University of California, San Francisco. The trial plans to enroll 32 participants.