Evaluation of a Sunscreen Product Compared with Reference Standards P3, P5 and P8 in Outdoor Conditions: a Randomized, Double-Blinded, Intra-individual Study in Healthy Subjects.

INTRODUCTION: The shortcomings of standardized sunscreen testing have been discussed in recent years, noting differences between how sunscreens perform in indoor clinical (in vivo) laboratory testing compared with real-life conditions. We previously developed an outdoor clinical method for ranking sunscreens by performance level. We used this method to test the performance of a new broad-spectrum sunscreen against International Organization for Standardization (ISO) reference products P3, P5 and P8. METHODS: Sixty-five healthy volunteers with individual typology angle (ITA) ≥ 28° (light to intermediate skin colour) participated in an outdoor study in Mauritius. Test areas were marked on their backs, which were treated with the different products: one commercially available broad-spectrum sun protection factor (SPF) 50 sunscreen [investigational product (IP)] and the three reference products P3 (SPF 15), P5 (SPF 30) and P8 (SPF 50+) from ISO norm 24444:2019 for SPF testing. The test areas were exposed for 2-3 h, depending on the baseline skin colour. They were also compared with an unprotected positive control area and a non-exposed negative control area. Clinical and colorimetry assessment of erythema and pigmentation were performed at 24 h and 8 days, respectively. RESULTS: Overall, according to this outdoor clinical testing method, the sunscreens' efficacy was ranked in an appropriate order given their established SPF levels, with higher SPFs giving greater protection against erythema and pigmentation. Between the different levels of SPF, the differences were statistically significant, for both clinical and colorimetry assessments. The new broad-spectrum SPF 50 IP performed similarly to the SPF 50+ (P8) reference product. Even the highest SPF products, SPF 50 and SPF 50+, had some instances of photoprotection failure. CONCLUSION: These findings confirm the feasibility of this outdoor clinical testing method in ranking sunscreens and provide further evidence, in addition to standardized SPF and UVA protection factor (UVAPF) testing, on how this new broad-spectrum SPF 50 sunscreen performs in extreme outdoor solar exposure: in line with reference product P8 (SPF 50+). TRIAL REGISTRATION NO: ISRCTN95394014.

The protective effect of a novel sunscreen against blue light.

BACKGROUND AND OBJECTIVE: Premature skin ageing, and skin hyperpigmentation are influenced by exogenous factors, such as ultraviolet radiation and blue light. In this study, we assess the protective effect of a sunscreen (TDF® Blu Voile Sunscreen) in protecting the skin against the harmful effects of blue light irradiation in vivo and through the in situ quantitative and qualitative evaluation of protein carbonylation in human skin explants. METHODOLOGY: The protective effect of the test product against blue light was first evaluated ex vivo on human skin explants. The treated and non-treated explants were exposed to 14 J/cm2 of blue light 460 nm following which the protein carbonylation was evaluated by in situ epifluorescence imaging and separation by high-resolution gel electrophoresis. To determine whether the test product could also protect against the immediate and persistent pigmenting effect of blue light, two randomized in vivo studies were conducted, which included respectively 17 subjects with a skin phototype of IV and V (Fitzpatrick classification) and 22 subjects with a skin phototype of IV, V, and VI (Fitzpatrick classification). The duration of the study for each subject was 2 days (D1 and D2) for immediate observations and 5 days (D1-D5) for persistent observations. Specific zones on the subjects' back were either left non-treated or treated with the test product and were then exposed to a unique dose of blue light 415 nm. The onset of pigmentation between the treated and exposed zones was then assessed relative to the non-exposed treated zone through colorimetric measurements of the Individual Typology Angle (ITAo ). RESULTS: Human skin explants treated with test product showed significantly lower levels of accumulated carbonylated proteins, with a protection of 82%, following exposure to blue light 460 nm. Findings of the in vivo studies also indicated that the test product presented significantly better protective efficacy against immediate and persistent pigmentation induced by blue light 415 nm. CONCLUSION: Hence, it can be concluded that the test product can protect against the oxidative stress as well as the immediate and persistent pigmentation induced by blue light.

CONTEXTE ET OBJECTIF: Le vieillissement prématuré de la peau et l'hyperpigmentation cutanée sont influencés par des facteurs exogènes, tels que les rayons ultraviolets et la lumière bleue. Dans cette étude, nous évaluons l'effet protecteur d'un écran solaire (TDF® Blu Voile Sunscreen) en matière de protection de la peau contre les effets nocifs de l'irradiation à la lumière bleue in vivo et par l'évaluation quantitative et qualitative in situ de la carbonylation des protéines dans des explants cutanés humains. MÉTHODOLOGIE: L'effet protecteur du produit testé contre la lumière bleue a d'abord été évalué ex vivo sur des explants cutanés humains. Les explants traités et non traités ont été exposés à 14 J/cm2 de lumière bleue à 460 nm, après quoi la carbonylation des protéines a été évaluée par imagerie par épifluorescence in situ et séparation par électrophorèse sur gel à haute résolution. Afin de déterminer si le produit testé pouvait également protéger contre la pigmentation immédiate et persistante dues à lumière bleue, deux études in vivo randomisées incluant respectivement 17 sujets ayant un phototype cutané IV et V (classification de Fitzpatrick) et 22 sujets ayant un phototype cutané IV, V et VI (classification de Fitzpatrick) ont été menées. La durée de l'étude pour chaque sujet était de 2 jours (J1 et J2) pour les observations immédiates et de 5 jours (J1 à J5) pour les observations persistantes. Des zones spécifiques du dos des sujets ont été laissées non traitées ou bien traitées avec le produit testé, et ont ensuite été exposées à une dose unique de lumière bleue à 415 nm. L'apparition de la pigmentation entre les zones traitées et exposées a ensuite été évaluée par rapport à la zone traitée non exposée par des mesures colorimétriques de l'angle typologique individuel (Individual Typology Angle, ITAo). RÉSULTATS: Les explants cutanés humains traités avec le produit testé ont montré des taux significativement plus faibles de protéines carbonylées accumulées, avec une protection de 82 %, après une exposition à la lumière bleue à 460 nm. Les résultats des études in vivo ont également indiqué que le produit testé présentait une efficacité protectrice significativement meilleure contre la pigmentation immédiate et persistante induite par la lumière bleue à 415 nm. CONCLUSION: Par conséquent, on peut conclure que le produit testé peut protéger contre le stress oxydatif ainsi que contre la pigmentation immédiate et persistante induite par la lumière bleue.

A novel method for evaluating the effect of pollution on the human skin under controlled conditions.

BACKGROUND: Generally considered as a major risk factor for various respiratory diseases, air pollution can also have a significant impact on the skin. To date, there is a plethora of cosmetics products with "anti-pollution" claims. However, these claims have not been fully substantiated with robust scientific evidence and currently there is no standardized method in place for validating the anti-pollution efficacy of cosmetics products. MATERIALS AND METHODS: This article discusses an innovative Controlled Pollution Exposure System (CPES) which allows quantified administration of pollutants on the skin and analysis of their direct impact. Using CPES, human subjects were exposed to ambient dust and ozone and sebum were sampled and analyzed for biomarkers. RESULTS: Following exposure of human subjects' skin to either ambient dust(100-450 µg/cm3 ) or ozone(100-1000 ppb), analysis of sebum revealed a significant decrease in squalene concentration, and significant increases in squalene monohydroperoxide and malondialdehyde concentration. CONCLUSION: The findings demonstrate cutaneous oxidative stress induced by ambient dust and ozone. The findings also demonstrate the efficacy of CPES to accurately measure the direct effect of controlled gaseous and particulate pollutants on human skin and indicate that squalene, squalene monohydroperoxide and malondialdehyde may serve as potent biomarkers for evaluating potential anti-pollution claims of cosmetics products.

Patient-Reported Outcomes in Acne Patients With Skin of Color Using Adapalene 0.3%-Benzoyl Peroxide 2.5%: A Prospective Real-World Study

Background: Patients with skin of color (SOC) and Fitzpatrick skin types (FST) IV­VI frequently develop acne. Objective: Evaluate subject-reported outcomes after treatment with adapalene 0.3%/ benzoyl peroxide 2.5% gel (0.3% A/BPO) in subjects with SOC and moderate to severe acne vulgaris. Methods: This was an open-label interventional study conducted in 3 countries (Mauritius, Singapore, and USA) in subjects of Asian, Latin-American, or black/African-American ethnicity, with an Investigator's Global Assessment (IGA) of moderate or severe facial acne (enrollment 2:1), and FST IV to VI. For 16 weeks, subjects applied 0.3% A/BPO (once daily) and utilized a skin care regimen (oil control foam wash and oil control moisturizer SPF30). Assessments included quality of life (QoL) and subject questionnaires, IGA, Investigator's Global Assessment of Improvement (GAI), postinflammatory hyperpigmentation (PIH; if present at baseline), and safety. Results: Fifty subjects were enrolled: 20 Asians, 17 black/African-Americans, and 13 Latin-Americans. Most had FST IV (74%) or V (22%), with moderate (70%; IGA 3) or severe (30%; IGA 4) acne. At week 16, 77% of subjects were satisfied or very satisfied with treatment, 56% of subjects had an IGA of 0 or 1 (clear/almost clear), and 87% had a good to excellent improvement in GAI. QoL improved throughout the study for all subjects; subject selection of "no effect at all" of acne on QoL increased from 16% of subjects at baseline to 55% at week 16. Of those with baseline PIH (60%), all were rated very mild to moderate. By week 16, the majority (75%) had no or very mild PIH, and the mean decrease in PIH was 27%. There were no adverse events leading to study discontinuation. Conclusion: Patients with SOC and moderate or severe facial acne reported high satisfaction with 0.3% A/BPO treatment and experienced good tolerability, improved QoL, treatment efficacy, and improvement in PIH. Clinicaltrials.gov number: NCT02932267 J Drugs Dermatol. 2019;18(6):514-520.