Moisturizers for Aging

(BIA Trial)

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two popular moisturizers, Vaseline and CeraVe, might reduce signs of skin inflammation in older adults with dry skin. Researchers aim to determine if these moisturizers can improve the skin’s barrier and reduce inflammation in the body. Participants will use one of the moisturizers for four weeks, then pause use to observe changes in skin and inflammation levels. This trial targets individuals aged 70 and older with dry skin on areas such as the arms, legs, and torso. As a Phase 4 trial, it involves FDA-approved treatments and seeks to understand their benefits for a broader patient population.

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 is the safety track record for these treatments?

Research has shown that both CeraVe Moisturizing Cream and Vaseline are generally safe for skin use. Studies have found that CeraVe, which contains ceramides and hyaluronic acid, helps keep skin hydrated without causing irritation. However, a few individuals might experience allergic reactions to certain ingredients.

Vaseline, made from white petroleum jelly, soothes and protects most skin types. It is usually well tolerated, but those with allergies or sensitive skin should exercise caution. Overall, both products are widely used and available without a prescription, indicating they are generally safe for everyday use. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments because CeraVe Moisturizing Cream and Vaseline offer unique benefits for aging skin. CeraVe stands out due to its inclusion of ceramides and hyaluronic acid, both of which are crucial for retaining skin moisture and improving the skin barrier, unlike many standard moisturizers. Vaseline, on the other hand, is known for its occlusive properties, effectively locking in moisture to protect the skin, which is different from many lighter moisturizers. These distinct mechanisms provide promising options for enhancing skin health as we age.

What evidence suggests that this trial's moisturizers could be effective for aging skin?

This trial will compare the effectiveness of CeraVe Moisturizing Cream and Vaseline in improving skin hydration and protection. Research has shown that CeraVe, which contains ceramides, can boost skin moisture and reduce dry skin symptoms, locking in moisture and reducing itchiness and dryness for up to 72 hours. Participants in this trial may receive CeraVe as part of their treatment. Vaseline, known for forming a barrier on the skin's surface, prevents water loss and supports skin health by creating a protective seal. Participants may also receive Vaseline as part of their treatment. Both treatments have shown promising results in soothing dry skin and promoting skin health. ^{6 7 8 9 10}

Who Is on the Research Team?

Katrina Abuabara, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. lorealdermatologicalbeauty.us lorealdermatologicalbeauty.us/cerave/education-resources/clinical-studies

Clinical Studies The cream increased skin hydration and demonstrated an immediate and sustained reduction in the visible signs of dry skin and subject perceived sensory ...

2. cerave.com cerave.com/skin-smarts/skincare-routines/a-simple-anti-aging-skincare-routine

Simple Anti-Aging Skincare Routine An anti-aging routine can help improve signs of aging, such as fine lines, wrinkles, and dullness. Discover CeraVe's simple anti-aging skincare routine.

3. cerave.com cerave.com/skincare/moisturizers/moisturizing-cream

Moisturizing Cream Our Moisturizing Cream with ceramides provides lasting hydration and helps maintain the skin barrier to soothe itchy, dry skin on the face and body.

4. simpleskincarescience.com simpleskincarescience.com/cerave-cream-review/

CeraVe Moisturizing Cream Review (REVISITED) It's the most powerful occlusive on planet earth, capable of preventing up to 98% of transepidermal water loss (TEWL). Like Caprylic/Capric Triglycerides (MCT ...

5. cerave.com cerave.com/skincare/moisturizers/intensive-moisturizing-cream

Intensive Moisturizing Cream Formulated with essential ceramides and skin-soothing ingredients, it helps restore the skin barrier and retain moisture for up to 72 hours.

6. ewg.org ewg.org/skindeep/products/1043549-CeraVe_Moisturizing_Cream/

EWG Skin Deep® | CeraVe Moisturizing Cream Rating Ingredient concerns ; LOW. Cancer ; HIGH. Allergies & Immunotoxicity ; MODERATE. Developmental and Reproductive Toxicity ; HIGH. Use Restrictions ...

7. cerave.com cerave.com/skincare/moisturizers/skin-renewing-night-cream

Skin Renewing Night Cream - Moisturizers Skin Renewing Night Cream has peptides to improve the appearance of fine lines and wrinkles, hydrating hyaluronic acid and barrier-replenishing ceramides.

8. uat-cd-us.cerave.com uat-cd-us.cerave.com/skincare/moisturizers/facial-moisturizers/skin-renewing-eye-cream

Skin Renewing Eye Cream CeraVe's Skin Renewing Eye Cream is an anti-aging eye cream with peptides formulated to help smooth, brighten, and improve the look of fine lines.

9. cerave.com cerave.com/ingredients-in-cerave

CeraVe Ingredients: Advanced Skincare Solutions CeraVe products are designed with beneficial skincare ingredients like ceramides, benzoyl peroxide, and niacinamide. Explore the ingredients in CeraVe.

10. amazon.com amazon.com/CeraVe-Anti-Aging-Anti-Wrinkle-Hyaluronic-Ceramides/dp/B01M1KQHM7

CeraVe Anti-Aging Face Cream SPF 30, Anti-Wrinkle ... It is formulated with encapsulated retinol and is clinically shown not to irritate the skin. Encapsulated retinol stabilizes and delivers retinol gradually.