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

45 Participants Needed

Trial Summary

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.

What data supports the idea that Mineral Sunscreens for Skin Tone Lightening is an effective treatment?

The available research shows that mineral sunscreens containing titanium dioxide and zinc oxide are effective in providing broad-spectrum protection against UV radiation. These ingredients are used in sunscreens to block harmful UV rays, which can help prevent skin damage and maintain an even skin tone. The research highlights that nano-sized versions of these minerals offer superior UV protection and reduce the whitening effect on the skin, making them more cosmetically appealing. Additionally, while these sunscreens are effective against UV radiation, they do not protect against visible light, which can also affect skin tone. Tinted sunscreens, which include iron oxides, are recommended for protection against visible light and are beneficial for conditions like hyperpigmentation. Overall, mineral sunscreens are effective for UV protection, but for comprehensive skin tone lightening, additional ingredients may be needed to address visible light exposure. ^{1 2 3 4 5}

What safety data exists for mineral sunscreens used for skin tone lightening?

The safety data for mineral sunscreens, specifically those containing nano-sized titanium dioxide (TiO2) and zinc oxide (ZnO), indicate that these ingredients are generally considered safe for use in sunscreens. Studies show that these nanoparticles do not penetrate beyond the outer layer of the skin (stratum corneum) and are unlikely to cause harm. The risk to humans from using these nano-structured UV filters is considered negligible, and they are safe for use at concentrations up to 25% in cosmetic products. Despite some public concerns about 'nano' technology, the benefits of using these sunscreens outweigh potential safety concerns. ^{1 2 5 6 7}

Is Sunscreen A, B, or C a promising treatment for skin tone lightening?

Yes, Sunscreen A, B, or C, which contain zinc oxide and titanium dioxide, are promising treatments. They provide strong protection against harmful UV rays, which can help prevent skin damage and support skin tone lightening. These sunscreens use nanoparticles to offer better UV protection and reduce the white appearance on the skin, making them more effective and cosmetically appealing. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of the study is to evaluate the whitening potential of different mineral and chemical sunscreens across multi-cultural skin tones through instrumentation, imaging, and self-assessment. It also aimed to evaluate the relationship between self-perception and objective measurements of whitening.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Titanium dioxide and zinc oxide nanoparticles in sunscreens: focus on their safety and effectiveness. [2022]

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

Photoprotection in the era of nanotechnology. [2013]

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

Photoprotection beyond ultraviolet radiation: A review of tinted sunscreens. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Metal oxide sunscreens protect skin by absorption, not by reflection or scattering. [2016]

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

Microfine zinc oxide is a superior sunscreen ingredient to microfine titanium dioxide. [2019]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Human safety review of "nano" titanium dioxide and zinc oxide. [2022]