Moisturizers for Aging

(BIA Trial)

Recruiting in San Francisco (>99 mi)

Overseen By Katrina Abuabara, MD

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Francisco

Must not be taking: Topical medications, Immunomodulatory, Anti-microbial

Disqualifiers: Inflammatory skin disease, Chronic inflammation, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, if you are currently using topical medications, oral systemic immunomodulatory treatments, or anti-microbial treatments, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment CeraVe Moisturizing Cream and Vaseline for aging skin?

Research shows that ceramide-containing moisturizers, like CeraVe, improve skin hydration and barrier function, which are important for aging skin. Additionally, Vaseline has been shown to decrease water loss from the skin, helping to maintain moisture. ^{1 2 3 4 5}

Are moisturizers like CeraVe and Vaseline safe for human use?

Moisturizers such as CeraVe and Vaseline are generally safe for human use, but some people may experience allergic reactions like contact dermatitis (skin irritation). It's important to be aware of potential allergens in these products, especially if you have sensitive skin. ^{2 5 6 7 8}

How does the treatment with CeraVe Moisturizing Cream and Vaseline differ from other treatments for aging skin?

CeraVe Moisturizing Cream is unique because it contains ceramides, which help restore the skin's natural barrier and improve hydration, while Vaseline is effective in reducing water loss from the skin. This combination targets both hydration and barrier protection, making it distinct from other moisturizers that may not address both aspects as effectively. ^{1 2 4 5 7}

What is the purpose of 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.

Research Team

Katrina Abuabara, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for older adults with dry skin who are interested in how moisturizers like CeraVe and Vaseline might affect their skin's barrier function and inflammation levels. Participants should be willing to apply these products daily for 4 weeks and undergo testing. Specific eligibility criteria details were not provided.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply one of two topical moisturizers (Vaseline or CeraVe) once daily for 4 weeks, followed by a 4-week period without moisturizer

8 weeks

3 visits (in-person) at baseline, week 4, and week 8

Follow-up

Participants are monitored for changes in skin barrier function, skin microbiome, and serum inflammatory markers

4 weeks

Treatment Details

Interventions

• CeraVe Moisturizing Cream
• Vaseline

Trial Overview The BIA Study tests if applying CeraVe or Vaseline can improve the skin barrier and reduce inflammation in aging individuals. It's a small-scale, randomized study where participants use one product for 4 weeks, then no product for another 4 weeks, while undergoing regular testing.

Participant Groups

Group I: CeraVe First Active Control 1 Intervention

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.

Group II: CeraVe Second Active Control 1 Intervention

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

Group III: Vaseline First Active Control 1 Intervention

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

Group IV: Vaseline Second Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+

Findings from Research

In a study of 54 patients with severe dry skin undergoing UVB phototherapy for psoriasis, a new cream containing glycerol, vaseline, and liquid paraffin showed greater improvement in skin conditions compared to a vaseline ointment.

The cream improved skin hydration within one week and was well tolerated, effectively reducing symptoms like erythema, flaking, and lichenification by the end of the four-week study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a skin protection cream for dry skin in patients undergoing narrow band UVB phototherapy for psoriasis vulgaris. Pacifico, A., Leone, G.[2015]

A study involving 30 volunteers with dry skin found that both a compounded moisturizer with 5% and 10% urea and a commercial moisturizer improved skin barrier function, but the commercial product was more effective in reducing transepidermal water loss (TEWL) after a single application.

The commercial moisturizer also significantly increased skin hydration more than the compounded product, suggesting that commercial formulations may be preferable for managing dry skin due to their better performance and higher acceptability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Urea-Based Compounding Moisturizers and Similar Commercial Products on Skin Barrier Function: A Randomized Biometric Study. Samadi, A., Naeimifar, A., Ahmad Nasrollahi, S., et al.[2022]

An 8-week study involving 35 female participants showed that a 3-step facial treatment program significantly improved the quality and appearance of photoaged skin without the use of traditional moisturizers.

The treatment led to measurable improvements in skin roughness, sebum levels, redness, and overall appearance, demonstrating its efficacy in enhancing skin hydration, clarity, and smoothness through cleansing and exfoliation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Approach to Enhancing the Quality and Appearance of Photoaged Skin Draelos, ZD.[2019]

A ceramide-containing moisturizer significantly improved skin hydration, barrier function, and pH in 24 senile subjects with xerosis, showing benefits after just one application and continued improvement over 28 days.

After 28 days of use, the ceramide moisturizer led to notable reductions in skin wrinkles and texture, indicating its potential as an effective treatment for dry skin in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 24-hr, 28-day, and 7-day post-moisturizing efficacy of ceramides 1, 3, 6-II containing moisturizing cream compared with hydrophilic cream on skin dryness and barrier disruption in senile xerosis treatment. Lueangarun, S., Tragulplaingam, P., Sugkraroek, S., et al.[2020]

In a study involving 31 patients with plaque-type psoriasis and 31 healthy controls, Vaseline jelly significantly reduced transepidermal water loss (TEWL) in psoriatic plaques, indicating improved epidermal barrier function.

The water-based formula increased stratum corneum hydration (SCH) in psoriatic plaques, suggesting that different types of moisturizers can have distinct effects on skin health in psoriasis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Skin Barrier Function in Psoriasis: The Impact of Emollients. Maroto-Morales, D., Montero-Vilchez, T., Arias-Santiago, S.[2021]

Common moisturizers like Aveeno, Cetaphil, and Cerave contain multiple potential allergens, with 12, 14, and 9 allergens respectively, most of which are infrequent and not included in standard allergy tests.

Awareness of these allergens can aid healthcare providers in diagnosing allergic contact dermatitis (ACD) in patients, especially when standard patch tests yield negative results or when ACD does not respond to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic Contact Dermatitis Secondary to Moisturizers. Cohen, SR., Cárdenas-de la Garza, JA., Dekker, P., et al.[2021]

In a study of 42 children aged 8 to 16 with atopic dermatitis, a ceramide-based moisturizer caused significantly less skin irritation compared to a 5% urea moisturizer, with mean irritation scores of 0.69 versus 1.43 respectively.

The majority of participants (62%) preferred the ceramide-based cream as their daily moisturizer, suggesting it may be a better option for minimizing irritation in young patients with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Potential for Irritation of a Ceramide-Based Moisturizer with a Urea-Based Moisturizer for Pediatric Atopic Dermatitis. Ho, VPY., Ma, E., Liew, HM., et al.[2021]

Not all over-the-counter moisturizers are beneficial for patients with atopic dermatitis (AD); some can worsen skin function and inflammation, highlighting the need for careful selection of products.

Physiological lipid-based barrier repair therapy (BRT) containing the right lipids in proper ratios can effectively reduce inflammation in AD and may also help with other inflammatory skin conditions, providing a promising alternative to standard moisturizers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing emollient therapy for skin barrier repair in atopic dermatitis. Elias, PM.[2023]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Evaluation of a skin protection cream for dry skin in patients undergoing narrow band UVB phototherapy for psoriasis vulgaris. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Urea-Based Compounding Moisturizers and Similar Commercial Products on Skin Barrier Function: A Randomized Biometric Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Novel Approach to Enhancing the Quality and Appearance of Photoaged Skin [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The 24-hr, 28-day, and 7-day post-moisturizing efficacy of ceramides 1, 3, 6-II containing moisturizing cream compared with hydrophilic cream on skin dryness and barrier disruption in senile xerosis treatment. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Study of Skin Barrier Function in Psoriasis: The Impact of Emollients. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Allergic Contact Dermatitis Secondary to Moisturizers. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing the Potential for Irritation of a Ceramide-Based Moisturizer with a Urea-Based Moisturizer for Pediatric Atopic Dermatitis. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Optimizing emollient therapy for skin barrier repair in atopic dermatitis. [2023]