Outdoor testing of the photoprotection provided by a new water-based broad-spectrum SPF50+ sunscreen product: two double-blind, split-face, randomized controlled studies in healthy adults

摘要

Purpose: Users often under-apply sunscreens, and one of the main reasons cited for this is the cosmetic formulation of the product. To address this, we developed a water-based sunscreen. The product underwent standard laboratory testing (ISO 24444: 2010) and was determined as sun protection factor (SPF) 50+. However, such laboratory testing does not take into account environmental factors of in-use conditions that could potentially affect sunscreen efficacy, particularly of new cosmetic formulations. We aimed to test this product in conditions more representative of real-life solar exposure, to confirm its reported laboratory efficacy. Methods: Two double-blind, randomized, controlled, split-face intra-individual studies were conducted during summer months in Barcelona. One study compared the product against an SPF15 control (reference standard P3 of ISO 24444: 2010), while the other compared against an SPF50+ control (another commercially available sunscreen). A technician applied the products before sun exposure: investigational product (IP) to one half of the face and the respective control product to the other. Subjects spent 4–6 hrs outdoors performing quiet activities, and sunscreens were reapplied at 2 hourly intervals. A dermatologist clinically scored facial erythema at baseline and at 24 hrs. Results: Sixty-five subjects were included in total. In both studies, skin treated with the IP showed no significant increase in clinical erythema scoring at 24 hrs. There were statistically significant differences between the IP and the SPF15, but not between the IP and the SPF50+ control. SPF15 did not protect all subjects against solar-induced erythema. Conclusion: These outdoor studies confirm the efficacy of this new SPF50+ water-based sunscreen in conditions that closer represent real-life sun exposure.