Skin Barrier Function and Inflammation in Aging: The BIA Study
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age70+
SponsorUniversity of California, San Francisco
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
CeraVe Moisturizing Cream
Other interventionCeraVe 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
DrugVaseline is a formulation of active ingredient white petrolatum, USP (100%), manufactured by Unilever, for topical skin use.
Treatment groups
32 Participants
are divided into 4 treatment groupsGroup A: CeraVe FirstActive comparator 1 intervention
Group B: CeraVe SecondActive comparator 1 intervention
Group C: Vaseline FirstActive comparator 1 intervention
Group D: Vaseline SecondActive comparator 1 intervention
Trial outcomes
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.
Time frame
8 weeksSecondary outcomes
1
Change in composite inflammation score
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.
Time frame
4 weeks2
Change in skin barrier function
Transepidermal water loss.
Time frame
4 weeks3
Change in skin barrier function
Changes in skin hydration will be measured and recorded using a Tewameter which quantifies the amount of water that evaporates from the skin's surface. Low TEWL values suggest better skin hydration.
Time frame
4 weeks4
Change in skin barrier function
pH.
Time frame
4 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Source ClinicalTrials.gov