Original articleSPF 100+ sunscreen is more protective against sunburn than SPF 50+ in actual use: Results of a randomized, double-blind, split-face, natural sunlight exposure clinical trial
Section snippets
Methods
This study was a single-center, randomized, split-face, double-blinded study conducted on a sunny day (March 21, 2016) during normal recreational skiing/snowboarding in Vail, Colorado. The study protocol was approved by the instituional review board IntegReview (Austin, TX), and all participants gave written informed consent, including a photo release, before enrollment (ClinicalTrials.gov identifier, NCT02952235).
Participants
A total of 199 participants were randomized to treatment: 99 to group 1 (left SPF 50+/right SPF 100+) and 100 to group 2 (left SPF 100+/right SPF 50+) (Fig 1). The study population consisted of 57.8% men (115 of 199) and 42.2% women (84 of 199), with an average age of 37.4 ± 16.3 years. Demographic and baseline characteristics for all randomized subjects may be found in Supplemental Table I (available at http://www.jaad.org).
Efficacy
During blinded evaluation conducted on the day following the exposure
Conclusions
This study evaluated the comparative efficacy of two marketed sunscreens that each utilize approved concentrations and combinations of US over-the-counter active UV filter ingredients. No other safety end points were evaluated and both products were well tolerated. As participants were blinded to the SPF values of the test products, the potential psychologic impact of label SPF on sun exposure and sunscreen use behaviors was not evaluated. If the sunscreen use patterns in the current study are
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2022, Journal of the American Academy of DermatologyCitation Excerpt :The ICNIRP also recommends the installation of sunscreen dispensers at worksites.87 Although there is no direct linear relationship between SPF values and efficacy, sunscreens with SPF 85 or 100 demonstrate increased effectiveness in preventing sunburns compared with those with SPF 50 (level II evidence).103,104 Additionally, as sunscreen users frequently apply <2 mg/cm2, the density used for testing by the United States Food and Drug Administration (FDA) and other entities, higher SPF sunscreens may be superior in their ability to counterbalance inadequate application.105,106
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2020, Journal of the American Academy of DermatologyCitation Excerpt :A sample size of 50 was prospectively estimated to provide at least 80% power to detect an overall difference between the 2 tested SPF levels with respect to bilateral sunburn comparison at the 0.05 significance level, 2-sided. This calculation assumes that after a single sunlight exposure, 32% of the population would experience more sunburn on the SPF 50+ side and 8% of the population more sunburn on the SPF 100+ side, as estimated from a previous study.7 Fifty-five healthy participants (37 women and 18 men) were randomly assigned: 27 to group 1 and 28 to group 2 (Fig 1, A).
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Funding sources: Supported by Johnson & Johnson Consumer Inc.
Drs Williams, Atillasoy, Maitra, and Wu are employees of Johnson & Johnson Consumer Inc. As sponsor employees and authors, they were involved in the design, management, data analysis, data interpretation, preparation, review, and approval of the article, as well as in the decision to submit it for publication. Dr Farberg serves as a consultant for Johnson & Johnson Consumer Inc. Dr Rigel serves as a consultant for Johnson & Johnson Consumer Inc, Beiersdorf, and Proctor & Gamble.
Presented in part at the 75th Annual Meeting of the American Academy of Dermatology, Orlando, FL; March 3-7, 2017.