The Experts below are selected from a list of 12 Experts worldwide ranked by ideXlab platform
Pascale Soto - One of the best experts on this subject based on the ideXlab platform.
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a new Ecamsule containing spf 40 sunscreen cream for the prevention of polymorphous light eruption a double blind randomized controlled study in maximized outdoor conditions
Cutis, 2009Co-Authors: Vincent A Deleo, Scott D Clark, Joseph F Fowler, Michel Poncet, Christian Loesche, Pascale SotoAbstract:Polymorphous light eruption (PMLE) is an idiopathic photodermatosis elicited by UV radiation (UVR). The objective of this double-blind, randomized, controlled, intraindividual, bilateral comparison was to determine the efficacy of the UVA filters (Ecamsule, avobenzone) present in the new sun protection factor (SPF) 40 sunscreen cream in preventing PMLE in maximized outdoor conditions (ie, exaggerated sun exposure). Safety also was assessed. Each participant was treated with SPF 40 sunscreen cream containing Ecamsule 3%, octocrylene 10%, avobenzone 2%, and titanium dioxide 5% (tetrad) on one side of the body and either an Ecamsule-deprived (triad-E) or avobenzone-deprived (triad-A) cream on the other side. Participants were subsequently exposed to incremental doses of sunlight for up to 6 days. The primary efficacy assessment was a composite relative success rate with 3 components. Success was defined as either a delayed time to onset of PMLE or a lower global severity of PMLE comparing one side of the body to the other side in the same participant. Safety evaluations included systemic adverse events (AEs). Of the 144 participants enrolled and randomized, 22 did not experience PMLE during the study duration under these maximized sun exposure conditions. A significantly greater number of successes were detected on the tetrad-treated side compared with either triad: 41 of 73 participants (56%) versus 8 of 73 participants (11%; P<.001) in the triad-E treatment group and 26 of 71 participants (36%) versus 11 of 71 participants (16%; P=.02) in the triad-A treatment group. Polymorphous light eruption appeared later with the tetrad than with either triad. The global severity of the PMLE flares was significantly lower with the tetrad than with both triads at end point (P<.001 and P=.02 for tetrad vs triad-E and tetrad vs triad-A, respectively). In this study, the SPF 40 sunscreen cream containing Ecamsule 3%, octocrylene 10%, avobenzone 2%, and titanium dioxide 5% prevented PMLE flares significantly better than similar formulations with only one of the UVA filters (triad-E treatment group, P<.001; triad-A treatment group, P=.02). The inclusion of both Ecamsule and avobenzone provides clinical benefit to patients with PMLE compared with formulations containing only one UVA filter.
Vincent A Deleo - One of the best experts on this subject based on the ideXlab platform.
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a new Ecamsule containing spf 40 sunscreen cream for the prevention of polymorphous light eruption a double blind randomized controlled study in maximized outdoor conditions
Cutis, 2009Co-Authors: Vincent A Deleo, Scott D Clark, Joseph F Fowler, Michel Poncet, Christian Loesche, Pascale SotoAbstract:Polymorphous light eruption (PMLE) is an idiopathic photodermatosis elicited by UV radiation (UVR). The objective of this double-blind, randomized, controlled, intraindividual, bilateral comparison was to determine the efficacy of the UVA filters (Ecamsule, avobenzone) present in the new sun protection factor (SPF) 40 sunscreen cream in preventing PMLE in maximized outdoor conditions (ie, exaggerated sun exposure). Safety also was assessed. Each participant was treated with SPF 40 sunscreen cream containing Ecamsule 3%, octocrylene 10%, avobenzone 2%, and titanium dioxide 5% (tetrad) on one side of the body and either an Ecamsule-deprived (triad-E) or avobenzone-deprived (triad-A) cream on the other side. Participants were subsequently exposed to incremental doses of sunlight for up to 6 days. The primary efficacy assessment was a composite relative success rate with 3 components. Success was defined as either a delayed time to onset of PMLE or a lower global severity of PMLE comparing one side of the body to the other side in the same participant. Safety evaluations included systemic adverse events (AEs). Of the 144 participants enrolled and randomized, 22 did not experience PMLE during the study duration under these maximized sun exposure conditions. A significantly greater number of successes were detected on the tetrad-treated side compared with either triad: 41 of 73 participants (56%) versus 8 of 73 participants (11%; P<.001) in the triad-E treatment group and 26 of 71 participants (36%) versus 11 of 71 participants (16%; P=.02) in the triad-A treatment group. Polymorphous light eruption appeared later with the tetrad than with either triad. The global severity of the PMLE flares was significantly lower with the tetrad than with both triads at end point (P<.001 and P=.02 for tetrad vs triad-E and tetrad vs triad-A, respectively). In this study, the SPF 40 sunscreen cream containing Ecamsule 3%, octocrylene 10%, avobenzone 2%, and titanium dioxide 5% prevented PMLE flares significantly better than similar formulations with only one of the UVA filters (triad-E treatment group, P<.001; triad-A treatment group, P=.02). The inclusion of both Ecamsule and avobenzone provides clinical benefit to patients with PMLE compared with formulations containing only one UVA filter.
Dominique Moyal - One of the best experts on this subject based on the ideXlab platform.
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sunscreens containing the broad spectrum uva absorber mexoryl sx prevent the cutaneous detrimental effects of uv exposure a review of clinical study results
Photodermatology Photoimmunology and Photomedicine, 2008Co-Authors: Anny Fourtanier, Dominique Moyal, Sophie SeiteAbstract:Background: UVA exposure of human skin mainly produces reactive oxygen species (ROS) leading to DNA, cell and tissue damage. It alters immune function, pigmentation and it is certainly responsible for a large part of photoaging changes. Moreover UVA is implicated in the etiology of several photodermatoses. As a consequence, to provide adequate protection, sunscreens or skin care products for daily use protective products need UVA absorbers combined with UVB ones. Aim: To assess the efficacy of sunscreens containing a broad-spectrum UVA absorber the Mexoryl® SX or Ecamsule and to compare formulations with and without it through a large number of clinical studies in human volunteers and patients. Methods: The following assessments were conducted: •Prevention of excessive pigmentation induced by UV exposure in Caucasian and Asian skins using a method that measures pigmentation protection factors (PPF). •Efficacy against DNA damage by measurement of pyrimidine dimer formation and p53 protein accumulation. •Protection of immune system using delayed type hypersensitivity (DTH) reactions to recall antigens, isomerization of urocanic acid (UCA), alteration of Langerhans cells (LC) density, morphology and function. •Reduction of epidermal and dermal alterations induced by repeated UVA or UV solar simulated radiation (SSR) using histology or immunohistology. •Prevention of the polymorphous light eruption (PMLE) in patients prone to develop this disease. Results: Mexoryl® SX-containing formulations showed a dose-dependent level of protection against pigmentation. For a same sun protection factor (SPF) the higher the UVA protection was, the higher was the PPF. Pyrimidine dimer formation and p53 accumulation were significantly reduced by formulations with Mexoryl® SX. In the studies looking at the suppression of DTH reactions to recall antigens by the different UV spectra, the LC alterations and the cis UCA formation, Mexoryl® SX formulations always showed a higher protective potency than sunscreen without it even when the protection against erythema was similar (products with same SPF). Mexoryl® SX formulations also prevented or significantly decreased to minimal, ferritin, tenascin and lysozyme expression induced by repeated UVA or SSR exposure. It also reduced the enhancement of collagenase 2 mRNA expression induced by SSR exposure. Finally PMLE study demonstrated that UVA protection was essential for the prevention of this photodermatose. Conclusion: Mexoryl® SX formulated in sunscreens or daily use products have been shown to be an effective UV absorber, leading to an increased efficacy of these products against a large number of biological damage induced by UVA, SSR or sun exposure.
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uva protection efficacy of sunscreens can be determined by the persistent pigment darkening ppd method part 2
Photodermatology Photoimmunology and Photomedicine, 2000Co-Authors: Dominique Moyal, Alain Chardon, Nikiforos KolliasAbstract:Background: The UVA-induced Persistent Pigment Darkening (PPD) in vivo has been proposed as an end point for the evaluation of UVA protection. Aims: This study was designed to determine whether PPD can be used to correctly evaluate the in vivo effectiveness of UVA filters such as oxybenzone, avobenzone, Ecamsule and zinc oxide concentrated and together with UVB filters. Methods: The UVA protection effectiveness of a number of commercial sunscreen products with either SPF 15 or SPF 30 was determined. Results: The UVA protection increased closely with the concentration of the UVA filters and was independent of UVB filters. The PPD method proved sensitive to all UVA filters irrespective of their range of absorbance within the UVA range. Conclusion: The results show PPD to be a stable end point inducible by all the UVA wavelengths, not affected by fluence rate, i.e. a reliable endogenous UVA dosimeter in the skin.
Sophie Seite - One of the best experts on this subject based on the ideXlab platform.
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sunscreens containing the broad spectrum uva absorber mexoryl sx prevent the cutaneous detrimental effects of uv exposure a review of clinical study results
Photodermatology Photoimmunology and Photomedicine, 2008Co-Authors: Anny Fourtanier, Dominique Moyal, Sophie SeiteAbstract:Background: UVA exposure of human skin mainly produces reactive oxygen species (ROS) leading to DNA, cell and tissue damage. It alters immune function, pigmentation and it is certainly responsible for a large part of photoaging changes. Moreover UVA is implicated in the etiology of several photodermatoses. As a consequence, to provide adequate protection, sunscreens or skin care products for daily use protective products need UVA absorbers combined with UVB ones. Aim: To assess the efficacy of sunscreens containing a broad-spectrum UVA absorber the Mexoryl® SX or Ecamsule and to compare formulations with and without it through a large number of clinical studies in human volunteers and patients. Methods: The following assessments were conducted: •Prevention of excessive pigmentation induced by UV exposure in Caucasian and Asian skins using a method that measures pigmentation protection factors (PPF). •Efficacy against DNA damage by measurement of pyrimidine dimer formation and p53 protein accumulation. •Protection of immune system using delayed type hypersensitivity (DTH) reactions to recall antigens, isomerization of urocanic acid (UCA), alteration of Langerhans cells (LC) density, morphology and function. •Reduction of epidermal and dermal alterations induced by repeated UVA or UV solar simulated radiation (SSR) using histology or immunohistology. •Prevention of the polymorphous light eruption (PMLE) in patients prone to develop this disease. Results: Mexoryl® SX-containing formulations showed a dose-dependent level of protection against pigmentation. For a same sun protection factor (SPF) the higher the UVA protection was, the higher was the PPF. Pyrimidine dimer formation and p53 accumulation were significantly reduced by formulations with Mexoryl® SX. In the studies looking at the suppression of DTH reactions to recall antigens by the different UV spectra, the LC alterations and the cis UCA formation, Mexoryl® SX formulations always showed a higher protective potency than sunscreen without it even when the protection against erythema was similar (products with same SPF). Mexoryl® SX formulations also prevented or significantly decreased to minimal, ferritin, tenascin and lysozyme expression induced by repeated UVA or SSR exposure. It also reduced the enhancement of collagenase 2 mRNA expression induced by SSR exposure. Finally PMLE study demonstrated that UVA protection was essential for the prevention of this photodermatose. Conclusion: Mexoryl® SX formulated in sunscreens or daily use products have been shown to be an effective UV absorber, leading to an increased efficacy of these products against a large number of biological damage induced by UVA, SSR or sun exposure.
Carlos Sanabria - One of the best experts on this subject based on the ideXlab platform.
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effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients a randomized clinical trial
JAMA, 2019Co-Authors: Murali K Matta, Robbert Zusterzeel, Nageswara R Pilli, Donna A Volpe, Jeffry Florian, Luke Oh, Edward D Bashaw, Vikram Patel, Issam Zineh, Carlos SanabriaAbstract:Importance The US Food and Drug Administration (FDA) has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies. Objective To determine whether the active ingredients (avobenzone, oxybenzone, octocrylene, and Ecamsule) of 4 commercially available sunscreens are absorbed into systemic circulation. Design, Setting, and Participants Randomized clinical trial conducted at a phase 1 clinical pharmacology unit in the United States and enrolling 24 healthy volunteers. Enrollment started in July 2018 and ended in August 2018. Interventions Participants were randomized to 1 of 4 sunscreens: spray 1 (n = 6 participants), spray 2 (n = 6), a lotion (n = 6), and a cream (n = 6). Two milligrams of sunscreen per 1 cm2was applied to 75% of body surface area 4 times per day for 4 days, and 30 blood samples were collected over 7 days from each participant. Main Outcomes and Measures The primary outcome was the maximum plasma concentration of avobenzone. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, and Ecamsule. Results Among 24 participants randomized (mean age, 35.5 [SD, 1.5] years; 12 (50%] women; 14 [58%] black or African American; 14 [58%]), 23 (96%) completed the trial. For avobenzone, geometric mean maximum plasma concentrations were 4.0 ng/mL (coefficient of variation, 6.9%) for spray 1; 3.4 ng/mL (coefficient of variation, 77.3%) for spray 2; 4.3 ng/mL (coefficient of variation, 46.1%) for lotion; and 1.8 ng/mL (coefficient of variation, 32.1%). For oxybenzone, the corresponding values were 209.6 ng/mL (66.8%) for spray 1, 194.9 ng/mL (52.4%) for spray 2, and 169.3 ng/mL (44.5%) for lotion; for octocrylene, 2.9 ng/mL (102%) for spray 1, 7.8 ng/mL (113.3%) for spray 2, 5.7 ng/mL (66.3%) for lotion, and 5.7 ng/mL (47.1%) for cream; and for Ecamsule, 1.5 ng/mL (166.1%) for cream. Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1. The most common adverse event was rash, which developed in 1 participant with each sunscreen. Conclusions and Relevance In this preliminary study involving healthy volunteers, application of 4 commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens. The systemic absorption of sunscreen ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen. Trial Registration ClinicalTrials.gov Identifier:NCT03582215