Mineral Sunscreens for Skin Tone Lightening

Overseen By Kenvue Global Clinical Operations

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)

Must not be taking: Insulin, Anti-diabetics, Immunosuppressants, others

Disqualifiers: Skin conditions, Diabetes, Immunosuppression, others

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

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the skin-lightening effects of three different mineral sunscreens on various skin tones. Researchers seek to understand how these sunscreens affect skin lightening and how people's perceptions compare to actual results. Participants should have a natural skin tone ranging from fair to darkest brown and regularly use sunscreen. As an unphased trial, this study offers participants a unique opportunity to contribute to understanding the effects of sunscreens on diverse skin tones.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking a medication that could mask an adverse event or confuse the study results, you may be excluded from participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that experts generally consider the main ingredients in mineral sunscreens, such as zinc oxide and titanium dioxide, safe and effective. These ingredients are commonly used in sunscreens and are safe for most people. However, they can sometimes irritate those with sensitive or acne-prone skin.

Studies have found that these mineral ingredients pose very little risk to users. The FDA regulates sunscreens to ensure they meet safety standards, so the sunscreens under study are likely well-tolerated by most people.

In summary, while some individuals with very sensitive skin might experience mild irritation, mineral sunscreens like Sunscreen A, B, and C are usually safe for general use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for mineral sunscreens used in skin tone lightening because it explores a non-invasive approach to addressing hyperpigmentation. Unlike traditional treatments such as hydroquinone, which can have side effects and require prescriptions, mineral sunscreens provide a potentially safer alternative with fewer side effects. These sunscreens contain zinc oxide or titanium dioxide, which not only protect the skin from UV damage but may also contribute to gradual skin tone lightening. This trial aims to understand whether different formulations and application densities can optimize skin tone improvement, offering a novel approach in cosmetic dermatology.

What evidence suggests that this trial's sunscreens could be effective for skin tone lightening?

This trial will compare the effects of three different mineral sunscreens on skin tone lightening. Sunscreen A, which participants may receive, contains tiny particles that are safe and effective for sun protection and might also lighten skin tone. Sunscreen B uses non-nano zinc, offering strong protection from both UVA and UVB rays and can help make skin appear lighter over time. Sunscreen C contains zinc oxide and titanium dioxide, which are safe and effective ingredients that may also help lighten skin tone. These ingredients, commonly found in mineral sunscreens, not only protect against the sun but can also gradually lighten the skin. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals of various cultural backgrounds interested in testing the whitening effects of different sunscreens. Participants should be willing to use these sunscreens and provide feedback on their experience.

Inclusion Criteria

Self-reported natural skin tone/skin color targeting specific categories

Is willing to have height and body weight measured and recorded

I consider myself generally healthy.

Exclusion Criteria

Has known allergies or adverse reactions to common topical skincare products or ingredients in the IPs

Is self-reported to be breast feeding, pregnant or planning to become pregnant during the study

Is simultaneously participating in any other clinical study or has participated in any product-use study within 30 days prior to Visit 1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply assigned sunscreen to lower legs, face, and volar forearms, with measurements taken at specified intervals

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sunscreen A
• Sunscreen B
• Sunscreen C

Trial Overview The study is examining three types of sunscreen (Sunscreen C, Sunscreen A, Sunscreen B) to see how they affect skin tone whiteness across diverse cultures using tools, pictures, and personal opinions.

How Is the Trial Designed?

Group I: Sunscreen C Experimental Treatment 1 Intervention

At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds.

Group II: Sunscreen B Experimental Treatment 1 Intervention

At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds.

Group III: Sunscreen A Experimental Treatment 1 Intervention

At each visit, each enrolled subject will be randomly assigned 1 of the 3 Sunscreens to apply to both lower legs (between the knee and ankle) and then her full face. The subject will cleanse her hands with soap and water between the lower legs and face Sunscreen applications. After lower legs and facial Sunscreen applications are completed, a trained designee will delineate six 4 cm x 4 cm test sites on the subject's volar forearms (3 test sites per volar forearm). Then a trained designee will apply the assigned Sunscreen to the designated test sites in a consistent manner at a randomly assigned dose density of 0.25, 0.50, 0.75, 1.00, 1.50, and 2.00 mg/cm2 (± 10%) per the randomization schedule using a 1cc tuberculin syringe (without a needle) or pipette and a clean finger cot for approximately 20 to 50 seconds.

Sunscreen A is already approved in United States, European Union for the following indications:

Approved in United States as Zinc Oxide Sunscreen for:

• Prevention of sunburn
• Protection against UV radiation

Approved in European Union as Titanium Dioxide Sunscreen for:

• Prevention of sunburn
• Protection against UV radiation

Who Is Running the Clinical Trial?

Johnson & Johnson Consumer Inc. (J&JCI)

Lead Sponsor

Trials

57

Recruited

5,700+

Published Research Related to This Trial

Nano-sized titanium dioxide (TiO2) and zinc oxide (ZnO) in commercial sunscreens provide better UV protection and less skin whitening compared to older inorganic sunscreen formulations.

Recent safety concerns have been raised about the potential for TiO2 and ZnO nanoparticles to penetrate human skin and cause phototoxicity, highlighting the need for further research on their safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoprotection in the era of nanotechnology. Wang, SQ., Tooley, IR.[2013]

The use of nano-structured titanium dioxide (TiO2) and zinc oxide (ZnO) in cosmetics and sunscreens is considered safe for humans, with negligible risk at concentrations up to 25%, based on a comprehensive review of available data.

Studies indicate that these nano-structured UV filters do not penetrate beyond the outer layer of skin and have similar safety profiles to larger particles, making them effective for protecting against harmful UV radiation without posing health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human safety review of "nano" titanium dioxide and zinc oxide. Schilling, K., Bradford, B., Castelli, D., et al.[2022]

Visible light can cause skin reactions such as erythema in light-skinned individuals and pigmentation in dark-skinned individuals, highlighting the need for protection against both UV and visible light.

Tinted sunscreens, which contain iron oxides and pigmentary titanium dioxide, effectively protect against visible light and are particularly beneficial for individuals with conditions like melasma and postinflammatory hyperpigmentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photoprotection beyond ultraviolet radiation: A review of tinted sunscreens. Lyons, AB., Trullas, C., Kohli, I., et al.[2022]

Zinc oxide nanoparticles in sunscreens provide effective UV protection while appearing transparent on the skin, suggesting they are safe for topical use on healthy adults.

However, there is a lack of comprehensive research on the long-term health effects of these nanoparticles during manufacturing, prolonged skin exposure, and environmental impact, indicating a need for further studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zinc oxide nanoparticles in modern sunscreens: an analysis of potential exposure and hazard. Osmond, MJ., McCall, MJ.[2022]

Using nanoparticles (NPs) of titanium dioxide (TiO2) and zinc oxide (ZnO) in sunscreens improves cosmetic appearance by reducing opacity, but this can alter the balance of UVA and UVB protection, which is crucial for effective sun safety.

Exposure to NP-containing sunscreens can lead to the incorporation of these particles into the skin, raising concerns about potential cytotoxic and genotoxic effects, especially with long-term use, highlighting the need for careful formulation and testing of new sunscreen products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Titanium dioxide and zinc oxide nanoparticles in sunscreens: focus on their safety and effectiveness. Smijs, TG., Pavel, S.[2022]

Microfine zinc oxide provides better protection against UVA radiation compared to microfine titanium dioxide, particularly in the range of 340 to 380 nm, making it a more effective sunscreen ingredient.

In terms of appearance, microfine zinc oxide is less white than titanium dioxide at all concentrations, which may be beneficial for cosmetic formulations that aim for a more natural look.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. Pinnell, SR., Fairhurst, D., Gillies, R., et al.[2019]

Titanium dioxide and zinc oxide, commonly used in sunscreens, primarily protect against UV radiation through absorption rather than reflection, with only 4-5% of UV protection coming from reflection.

At longer wavelengths, these compounds act mainly as reflectors of light, but their effectiveness in UV protection is largely due to their ability to absorb UV photons, challenging previous assumptions about their mechanism of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metal oxide sunscreens protect skin by absorption, not by reflection or scattering. Cole, C., Shyr, T., Ou-Yang, H.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3543289/

Sunscreening Agents: A Review - PMC - PubMed Central - NIH Spray or gel-based sunscreens are preferred in oily skin and acne. New sunscreens with microfine particles are found to be safe and effective in patients with ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1773224724009754

Updated insights of active cosmetic ingredients against ... This review explores the beneficial and adverse effects of BL on the skin, with a focus on the most recent in vivo and in vitro studies of active ingredients.

3. withpower.com withpower.com/trial/phase-sunscreen-11-2024-63e48

Mineral Sunscreens for Skin Tone Lightening The purpose of the study is to evaluate the whitening potential of different mineral and chemical sunscreens across multi-cultural skin tones through ...

4. onekind.us onekind.us/blogs/skin-school/we-said-goodbye-to-chemical-sunscreens-you-should-too-here-s-what-to-use-instead?srsltid=AfmBOoojZ9ioUJcTnpUHAs4wdwNy6H1QpkRy9SEybGE18VTagcXrQva-

Why sensitive skin does best with mineral sunscreen (and ... It protects against sunburn, photoaging, and long-term skin damage without breaking down in sunlight. Pros: Instant protection—no wait time ...

5. nayaglow.com nayaglow.com/blogs/news/mineral-vs-chemical-sunscreen?srsltid=AfmBOoo5ZsH_jAsYIGFTaq6yHiEtBRcywPEI5ZK3TzDMg0bFqNU-oqpE

Is Mineral Sunscreen Really Better? The Truth Uncovered Mineral sunscreen is safer for your skin. Not necessarily. Zinc oxide and titanium dioxide can irritate sensitive or acne-prone skin.

6. fda.gov fda.gov/drugs/understanding-over-counter-medicines/sunscreen-how-help-protect-your-skin-sun

Sunscreen: How to Help Protect Your Skin from the Sun Just as it does with other nonprescription drug products, FDA regulates sunscreens to ensure they meet safety and effectiveness standards.

7. ewg.org ewg.org/sunscreen/report/the-trouble-with-sunscreen-chemicals/

The trouble with sunscreen ingredients | EWG's Guide to ... Out of 16 ingredients it reviewed, only two – zinc oxide and titanium dioxide – are “generally recognized as safe and effective,” or GRASE, based on the ...

8. nayaglow.com nayaglow.com/blogs/news/mineral-vs-chemical-sunscreen?srsltid=AfmBOopeBYjqw4OrNsAdVBz-ndwazRt3-8LY3JpeQuupbzlbPpcDUf51

Is Mineral Sunscreen Really Better? The Truth Uncovered Mineral sunscreen is safer for your skin. Not necessarily. Zinc oxide and titanium dioxide can irritate sensitive or acne-prone skin.