This study is designed to assess the systemic exposure and pharmacokinetics of sunscreen active ingredients (avobenzone, oxybenzone, ecamsule, octocrylene homosalate, octisalate and octinoxate) when sunscreen product is applied under maximal use conditions.
Part 1 is an open-label, randomized, 4-arm study in 24 healthy adult subjects with the primary objective to explore whether the active components (avobenzone, oxybenzone, ecamsule and octocrylene) of 4 sunscreen products (1 sunscreen product in each arm) are absorbed into the systemic circulation when a sunscreen product is applied under maximal use conditions.
One sunscreen product with the highest avobenzone exposure will be selected for the second part of the study. If there is no quantifiable exposure of avobenzone for any of the sunscreen products, the formulation with the highest oxybenzone exposure will be selected for Part 2. In addition, 3 new sunscreen products are included in Part 2.
Part 2 is an open label, 4-arm study in 48 healthy adult subjects with the primary objective to assess the pharmacokinetics of the active components in the selected product from Part 1 and 3 additional products with a combination of active ingredients (avobenzone, oxybenzone, octocrylene, ecamsule homosalate, octisalate and octinoxate as applicable/contained in the different products).

开始日期2018-07-18

申办/合作机构

US Food & Drug Administration

[+1]

NCT05865431 / CompletedN/AIIT

Singlet Oxygen Quantification After Skin Exposure to Ultraviolet A (UVA) Light

The objective of this study is quantification of singlet oxygen species in the skin after exposure to Ultraviolet A (UVA) light

开始日期2017-03-17

申办/合作机构

University of California, Davis

NCT00530387 / CompletedN/A

A Prospective, Open, Multi-Centre Photopatch Test Study of Patients Suspected of Photoallergy to Organic Sunscreens and Topical Nonsteroidal Anti-inflammatory Drugs Used Within Europe.

It is known that people can develop an allergic skin reaction to a substance which is placed on the skin and then subjected to sunlight. This process is called Photocontact allergic dermatitis. It is known that people can develop Photocontact allergic dermatitis to sunscreen chemicals (filters) and also cream forms of pain-killing drugs called nonsteroidal anti-inflammatory drugs (NSAIDs).
The purpose of this study is to determine the frequency of Photocontact allergic dermatitis to 19 sunscreen filters and 5 topical NSAIDs in 1,000 European patients who present to a dermatologist with a sun-exposed site dermatitis.
Each participant will have the 24 test agents plus one control of petrolatum applied to the skin of the back for 24 or 48 hours. After removal of the substances, the area of skin will be exposed to a precise amount of ultraviolet-A light. The area is then assessed 24, 48 and 72 hours later to see if a photocontact allergic reaction has occured. This method is known as photopatch testing.
The study will run for one year, during which time it is planned to recruit 1,000 patients.

开始日期2008-07-01

申办/合作机构

NHS Tayside

100 项与阿伏苯宗相关的临床结果

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100 项与阿伏苯宗相关的转化医学

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100 项与阿伏苯宗相关的专利（医药）

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163

项与阿伏苯宗相关的文献（医药）

2024-03-01·Journal of hazardous materials

Unveiling the toxic effects, physiological responses and molecular mechanisms of tobacco (Nicotiana tabacum) in exposure to organic ultraviolet filters

Article

作者: Peng, Xia ; Chen, Kebin ; Jiang, Dong ; Tang, Yangcan ; Pi, Xin ; Yang, Runke ; Li, Ning ; Yang, Guoqun ; Cui, Chuantong ; Huang, Li-Jun

Exposure to organic ultraviolet (UV) filters has raised concerns due to their potential adverse effects on environments. However, their toxic mechanisms on plants remain elusive. In this study, using integrative physiological and transcriptomic approaches we investigated the physiological and molecular responses to three representative UV filters, namely oxybenzone (OBZ), avobenzone (AVB), and octinoxate (OMC), in an agricultural model plant tobacco. The exposure to UV filters disrupts the functionality of photosystem reaction centers and the light-harvesting apparatus. Concurrently, UV filters exert a suppressive effect on the expression of genes encoding Rubisco and Calvin-Benson cycle enzymes, resulting in a decreased efficiency of the Calvin-Benson cycle and consequently hampering the process of photosynthesis. Exposure to UV filters leads to significant generation of reactive oxygen species within tobacco leaves and downregulation of oxidoreductase activities. Moreover, UV filters promote abscisic acid (ABA) accumulation by inducing the expression of ABA biosynthesis genes whereas repress indole-3-acetic acid (IAA) biosynthesis gene expression, which induce leaf yellowing and slow plant growth. In summary, the organic UV filters exert toxic effects on tobacco growth by inhibiting chlorophyll synthesis, photosynthesis, and the Calvin-Benson cycle, while generating excessive reactive oxygen species. This study sheds light on the toxic and tolerance mechanisms of UV filters in agricultural crops.

2023-12-01·Chemosphere

Single and mixture toxicity evaluation of avobenzone and homosalate to male zebrafish and H295R cells.

Article

作者: Ji, Kyunghee ; Seo, Ye Eun ; Ka, Yujin ; Kho, Younglim ; Lee, Sujin ; Shin, Hyewon ; Lee, Bomi ; Lee, Inhye

Avobenzone and homosalate are widely used in sunscreens to provide ultraviolet (UV) protection, either as single compounds or in combination. Some UV filters exhibit estrogenic or anti-androgenic activities, however, studies regarding their interactions and toxicity in mixtures are limited. In this study, the effect of the toxicity of a binary mixture comprising avobenzone (0.72 μg L^-1) and homosalate (1.02 and 103 μg L^-1) on steroid hormone biosynthesis were investigated using male zebrafish and human adrenocortical carcinoma (H295R) cells. In fish exposed to homosalate, a significant decrease in the gonadosomatic index, testosterone level, and transcription of several genes (e.g, hsd3b2, cyp17a1, and hsd17b1) and a significant increase in the hepatosomatic index, liver steatosis, 17β-estradiol level, and transcription of vtg gene were observed. These results suggest that estrogenic and anti-androgenic effects of homosalate were mediated by the steroidogenic pathway. The presence of 0.72 μg L^-1 of avobenzone augmented the anti-androgenic responses in male fish. The testosterone level in the H295R cells were significantly decreased after they were exposed to homosalate alone or in combination with avobenzone, which is consistent with observations in male zebrafish. Further studies need to be conducted to understand the endocrine disrupting properties of long-term exposure to substances typically used in sunscreens.

2023-10-01·International journal of cosmetic science

Influence of sunscreen formulation on the transfer of mineral and organic ultraviolet filters from skin to seawater in simulated ocean bathing tests.

Article

作者: Reynertson, Kurt A ; Sun, Frank ; Lewis, Alan ; Saxe, Jennifer K ; Mullins, Larry ; Jones, Randy

OBJECTIVE:

Significant research and regulatory attention have been focussed on the potential for some ultraviolet filters (UVFs) to rinse off from beachgoers' skin into seawater leading to exposure to sea life, especially coral reefs. The amount of UVFs potentially rinsed from skin during recreational beach activities has not been well studied, leading to uncertainty about the potential magnitude of aquatic UVF exposure due to changes in sunscreen use patterns. This study quantifies rinse-off of UVFs in sunscreen from skin into synthetic seawater and identifies differences in rinse-off quantity due to formulation type with a goal of informing future modelling efforts aimed at estimating UVF exposure to sea life associated with recreational activities at the beach.

METHODS:

UVF rinse-off from skin during recreation in seawater was simulated by applying eight different sunscreen products to porcine skin samples followed by three periods of shaking in synthetic seawater totalling 40 min. The rinsed mass of six UVFs - zinc oxide, titanium dioxide, avobenzone, homosalate, octisalate, and octocrylene - was determined analytically in synthetic seawater and in extractant rinsate from glassware for organic UVFs and compared among formulas.

RESULTS:

Among the 22 UVF-formulation combinations tested, 19 resulted in less than 10% of the applied UVF rinsed from skin. All formulation-UVF combinations where the formula types were water-in-oil (reverse phase) emulsions or anhydrous resulted in 5% or less of the applied UVF rinsed to synthetic seawater. Sunscreens formulated as oil-in-water emulsions yielded higher rinse-off percentages for all UVFs tested, with a maximum of 20% rinse-off of avobenzone in one lotion.

CONCLUSION:

The potential for sunscreen UVF rinse-off is significantly influenced by formulation and is generally well below the prior assumed rinse-off levels used to estimate risk. Formulation consideration is therefore essential for accurate exposure models used in environmental risk assessment. Anhydrous and reverse phase (water-in-oil) sunscreen formulations tested resulted in lower UVF transfer from skin to synthetic seawater in simulated ocean bathing tests and as a result, are expected to yield lower UVF exposures to sea life. This approach can be used in predictive environmental exposure models to support ecologically safe sunscreen formulation design.

项与阿伏苯宗相关的新闻（医药）

2006-07-24

·BioSpace

FDA Approves A New Over-The-Counter Sunscreen Product

NEW YORK, July 24 /PRNewswire/ -- L'Oreal USA, the U.S. subsidiary of global beauty company L'Oreal SA, announced today that the U.S. Food and Drug Administration has approved a new sunscreen formula containing Mexoryl(TM) SX, a unique organic filter that is highly protective against short UVA waves. It is the first time the FDA has approved a new sunscreen filter since 1988. Mexoryl(TM) SX is owned by L'Oreal, and is only available in L'Oreal products. Mexoryl(TM) SX is the first and only sun filter available in the U.S. in a photo-stable form designed to protect the skin from the harmful short UVA waves (320-340 nms) of the sun. UVA waves (320-400 nms) account for up to 95% of the UV radiation that reaches the Earth's surface. Mexoryl(TM) SX is particularly effective against short UVA waves. Unlike other filters that offer UVA protection, Mexoryl(TM) SX is photo-stable, meaning it does not degrade when it is exposed to the sun for long periods of time. Mexoryl(TM) SX was first patented by L'Oreal in 1982, and is now sold in the company's products in Europe, Asia, Canada and Latin America. "Mexoryl(TM) SX is owned by L'Oreal, and is only available in L'Oreal products. It is the culmination of many years of research and testing," said Alan Meyers, Senior Vice President of Research and Development at L'Oreal USA. "We are pleased that the FDA has approved L'Oreal USA's use of Mexoryl(TM) SX in a new sunscreen formula. We now have the tools to give U.S. consumers very high UVA protection as well as broad-spectrum sun protection." Mexoryl(TM) SX, which particularly covers short UVA waves, has been approved as part of a new L'Oreal USA daily moisturizing cream with sunscreen that also contains Octocrylene and Avobenzone (Parsol 1789) -- ingredients that offer coverage against, respectively, UVB waves and long UVA waves. When combined with a traditional UVA filter that provides protection against the longer UVA waves, formulations containing Mexoryl(TM) SX provide complete broad-spectrum sun protection. L'Oreal sought to first introduce Mexoryl(TM) SX to the U.S. market as part of a daily moisturizing cream with sunscreen because the company believes that U.S. consumers should consider UVA protection to be an important part of their daily skincare routine. UVA waves represent 90% - 95% of all UV rays that reach the Earth. Unlike UVB waves, which remain primarily at the epidermal level, UVA waves penetrate deeper into the dermis or base layer of the skin. UVA waves can also pass through glass, and occasionally through clothing. "Most people think about UVB rays as being the problem in terms of sun exposure. In reality, UVA accounts for over 80% of the damage that occurs to the skin in terms of aging, DNA damage and ultimately skin cancer," said Dr. Darrell Rigel, clinical professor of dermatology at New York University Medical Center. "UVA rays are present all year long (even in the winter) and they can penetrate through clouds and windows. When protecting your skin you need a product that you can use every day against the harmful effects of UVA and UVB rays." The first L'Oreal product containing Mexoryl(TM) SX to be released in the U.S. market will be ANTHELIOS SX, a daily moisturizing cream with sunscreen that will be sold by the L'Oreal brand La Roche-Posay. The product will be sold from this Fall and will be available in select pharmacies and drugstores as well as doctors' offices. L'Oreal also intends to launch daily moisturizing products containing Mexoryl(TM) SX in some of its other brands in the future, and to introduce more sunscreen formulations containing Mexoryl(TM) SX. ABOUT L'OREAL RESEARCH AND DEVELOPMENT L'Oreal is the beauty industry's leader in scientific and consumer research. L'Oreal invests more than 3% of sales in Research and Development each year, and in 2005 committed $625 million to cosmetic and dermatological research. Over 3,100 employees work in the group's 14 research centers and 13 evaluation centers, which span three continents. Last year, L'Oreal's scientists developed over 4,000 formulas and filed over 500 patents. ABOUT L'OREAL USA L'Oreal USA, headquartered in New York City, with 2005 sales of over $4 billion and 7,900 employees, is a wholly-owned subsidiary of L'Oreal SA, one of the world's leading beauty companies. L'Oreal USA has Research and Development, Manufacturing and Distribution facilities across eight states in the U.S., including New York, New Jersey, Kentucky, Arkansas, Illinois, Ohio, Colorado and Texas. L'Oreal's impressive portfolio of brands includes Lancome, Giorgio Armani, Shu Uemura, L'Oreal Paris, Garnier, Vichy, Biotherm, La Roche-Posay, L'Oreal Professionnel and Kerastase. The U.S. is the base for the product development, international marketing and advertising for L'Oreal's eight American brands: Maybelline New York, Soft-Sheen.Carson, Kiehl's Since 1851, Ralph Lauren, Redken 5th Avenue NYC, Matrix, Mizani and SkinCeuticals. Source: L'Oreal USA

100 项与阿伏苯宗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03015	阿伏苯宗	D02B	DB09495

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
晒伤	美国	Allergan, Inc.	1988-09-30

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03582215 (CTgov)	临床1期	-	72	Part 1: Cream (Part 1: Cream)	繭廠範壓鬱淵蓋蓋選鹽(壓積製顧夢膚醖構鏇構) = 膚夢淵壓鏇鹽範窪鹽齋簾壓繭範壓鹽鹽襯廠鹹 (餘襯範製齋廠鬱餘製壓, 餘構糧遞膚艱築繭選衊 ~ 艱積鏇構襯範淵艱醖醖) 更多	-	2020-04-21
				Octocrylene+Avobenzone+Oxybenzone (Part 1: Lotion)	繭廠範壓鬱淵蓋蓋選鹽(壓積製顧夢膚醖構鏇構) = 鏇鹽鹹齋衊遞衊窪鹹繭簾壓繭範壓鹽鹽襯廠鹹 (餘襯範製齋廠鬱餘製壓, 壓製範蓋願夢糧築餘範 ~ 衊願網鑰壓簾鹹觸製夢) 更多