A Single-Center, Clinical Study to Evaluate the Whitening Effect of Mineral Sunscreens in Multi-Cultural Skin Tones Through Instrumentation Measurements, Imaging, and Self-Assessments
Johnson & Johnson Consumer Inc. (J&JCI) sponsored a single-center clinical study at Validated Claim Support to evaluate the whitening effect of mineral sunscreens in multi-cultural skin tones through instrumentation measurements, imaging, and self-assessments. The goal of this study was to test the efficacy of six different mineral sunscreens on participants with Fitzpatrick scores IV-VI and to determine if the sunscreens caused any visible changes in skin tone.
Study Methodology
The study enrolled participants who were randomly assigned two out of six sunscreens to apply to their lower legs at Visit 1 (Day 1). Participants then selected one of the two sunscreens to apply to their entire face. After application to the face and lower legs, a trained designee applied the remaining six sunscreens to six test sites on the participants’ volar forearms using a tuberculin syringe and a clean finger cot for 20-50 seconds. The sunscreens were randomly assigned to the test sites at a dose of 2.00 +- 0.05 milligrams per centimeter square (mg/cm^2).
Self-Assessment
As part of the clinical trial, participants completed self-assessments to evaluate the appearance of their skin after applying mineral sunscreen products. These assessments included questions about the skin’s overall appearance, including its brightness, clarity, and texture.
Participants were asked to rate their satisfaction with the product on a scale of 1 to 10, with 10 being the most satisfied. The results of the self-assessments were combined with the objective measurements taken by trained designees to provide a comprehensive evaluation of the whitening effect of mineral sunscreens on multicultural skin tones.
Clinical Findings
The results of the study showed that all six mineral sunscreens did not cause any visible whitening effect on multicultural skin tones. There were no significant differences in skin tone between the six test sites on the participants’ volar forearms.
Participants’ self-assessments also showed no visible changes in skin tone after sunscreen application. Instrumentation measurements and imaging further confirmed these findings.
Significance of the Study
This study is significant because it emphasizes the importance of testing skincare products on all skin types and tones. J&J and Validated Claim Support recognize the need for inclusive research that accurately represents diverse populations. This study supports the claim that mineral sunscreens are safe and effective for use on multicultural skin tones, without causing any visible changes in skin tone.
Additionally, the findings of this study can inform product development and formulation for companies in the personal care industry. By conducting research that includes diverse populations, companies can create products that meet the needs and preferences of a wider range of consumers. Furthermore, this study can contribute to promoting the overall health and well-being of individuals by encouraging the use of safe and effective sunscreen products that do not have a negative impact on the visible appearance of their skin.
Wide Reaching Implications of the Study
Generally suncreens are only tested on Fitzpatrick Skintypes I, II, and II for SPF efficacy, and its important to note that SPF data alone is not an indicator of how a product will perform in the real world. As the normal SPF skintypes are the lightest or palest varieties, often times in-use and efficacy testing never consider the visible appearance of sunscreen films on darker skin. Protection from UV radiation is about much more than just the underlying SPF: if someone doesn’t like the look or feel of a product, they are less likely to follow the label claim requirements for reapplication. If a product causes a white or purple hue on their skin, they’ll likely be less apt to reapply, or apply in the first place. The mineral based sunscreens in particular tend to trend towards casting a pale, whitish hue on Fitzpatrick types IV, V, and VI.
If products are to be truly designed with “All Skintypes” in mind, Validated Claim Support believes they must really be tested on all skin types in some fashion. Since the current FDA SPF Monographs effectively don’t allow for testing on darker skintypes for the regulated SPF and In Vivo Label Claim Final Rule test, it is really important that brands conduct secondary market In-Use testing to ensure that the products are usable by individuals with all skintones, not just the lighter ones.
Implications for Personal Care Industry
The findings of this study have important implications for the personal care industry. Companies that manufacture skincare products must take into account the diversity of their consumers and ensure that their products are tested on all skin types and tones.
Inclusivity in research and development can lead to more effective and safe products that cater to the diverse needs of consumers. This study sets a benchmark for future research on skincare products and emphasizes the need for diverse representation in clinical studies.
Conclusion
Overall, this single-center clinical study on mineral sunscreens and their visible appearance on darker skin tones and panelists ranging from Fitzpatrick scores IV-VI provides valuable insights into the importance of inclusive research for personal care products.
It reaffirms the safety and effectiveness of mineral sunscreens for use on multi-cultural skin tones, without causing any visible changes in skin tone. J&J and Validated Claim Support are committed to continued research and development of skincare products that cater to the diverse needs of all consumers.
