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]

NCT01695356 / Completed临床4期IIT

A Double Blind Randomized Study Comparing the Ultraviolet (UV) Photoprotection With UV Plus Visible Light Photoprotection in the Treatment of Melasma.

Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible light sunscreen. Visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 25 per group. The purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.

开始日期2012-09-01

申办/合作机构

Universidad Autónoma De San Luis Potosí

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 项与奥克立宁相关的临床结果

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100 项与奥克立宁相关的转化医学

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100 项与奥克立宁相关的专利（医药）

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项与奥克立宁相关的文献（医药）

2024-02-01·The Science of the total environment

Transcriptomic profiles of brains in juvenile Atlantic cod (Gadus morhua) exposed to pharmaceuticals and personal care products from a wastewater treatment plant discharge

Article

作者: Ræder, Erik Magnus ; Pampanin, Daniela M ; Magnuson, Jason T ; Schlenk, Daniel ; Sydnes, Magne O

Pharmaceuticals and personal care products (PPCPs) are frequently detected in marine environments, posing a threat to aquatic organisms. Our previous research demonstrated the occurrence of neuroactive compounds in effluent and sediments from a wastewater treatment plant (WWTP) in a fjord North of Stavanger, the fourth-largest city in Norway. To better understand the influence of PPCP mixtures on fish, Atlantic cod (Gadus morhua) were caged for one month in 3 locations: site 1 (reference), site 2 (WWTP discharge), and site 3 (6.7 km west of discharge). Transcriptomic profiling was conducted in the brains of exposed fish and detection of PPCPs in WWTP effluent and muscle fillets were determined. Caffeine (47.8 ng/L), benzotriazole (10.9 ng/L), N,N-diethyl-meta-toluamide (DEET) (5.6 ng/L), methyl-1H-benzotriazole (5.5 ng/L), trimethoprim (3.4 ng/L), carbamazepine (2.1 ng/L), and nortriptyline (0.4 ng/L) were detected in the WWTP effluent. Octocrylene concentrations were observed in muscle tissue at all sites and ranged from 53 to 193 ng/g. Nervous system function and endocrine system disorders were the top enriched disease and function pathways predicted in male and female fish at site 2, with the top shared canonical pathways involved with estrogen receptor and Sirtuin signaling. At the discharge site, predicted disease and functional responses in female brains were involved in cellular assembly, organization, and function, tissue development, and nervous system development, whereas male brains were involved in connective tissue development, function, and disorders, nervous system development and function, and neurological disease. The top shared canonical pathways in females and males were involved in fatty acid activation and tight junction signaling. This study suggests that pseudopersistent, chronic exposure of native juvenile Atlantic cod from this ecosystem to PPCPs may alter neuroendocrine and neuron development.

2024-02-01·Regulatory toxicology and pharmacology : RTP

Prioritization of chemicals in personal care products based on persistent, bioaccumulative and toxic (PBT) potential: An Indian perspective

Article

作者: Rajan Jeyakumaran, Sowmiya ; Kannan, Uthradevi ; Senthilkumar, Varshini ; John, Jabez ; Paramasivam, Balakrishnan ; Vinodh, Kevin ; Balakrishnan, Abirami

Numerous organic ingredients present in Personal care products (PCPs) are being detected in sewage which has a high potential to impact the environment. These compounds are called as Emerging contaminants (ECs) or Contaminants of emerging concern. However, the information on the source and occurrence of ECs present in PCPs is very minimal. Specifically, information on the persistence (P), bioaccumulation (B) and toxicity (T) is very scarce. The determination of PBT properties is a complex task given the magnitude of chemicals, thus it is necessary to have a tool to quickly screen and prioritize the most important compounds. Estimation Program Interface (EPI) Suite™ is one such tool authorized by United States Environmental Protection Agency (US EPA) for screening purposes. In the present study, several organic compounds present in the PCPs viz. body lotion, sunscreens, moisturizers, hair dyes, and some hair care products were identified and their PBT property was estimated. The results from the study indicate that the order of increasing occurrence of PBT chemicals is sunscreens > moisturizers > body lotion > hair care products > hair dyes. The prioritized compounds were given rank 1 (maximum concern) to rank 4 (minimum concern). From the results, the compounds octocrylene in sunscreens and butylphenyl methylpropional in body lotions were prioritized as Rank 1.

2023-12-01·Chemosphere

Organic ultraviolet absorbents in soils and typical plants from an industrial metropolis in China: Concentrations, profiles and environmental implications.

Article

作者: Sun, Jiazheng ; Ma, Jiayi ; Tang, Zhenwu ; Xing, Xiangyang ; An, Di

There is accumulating evidence of the toxicity of organic ultraviolet absorbers (OUVAs); however, limited information is available regarding the presence of OUVAs in terrestrial environments and organisms. Therefore, this study was conducted to investigate the occurrence of 11 OUVAs in soils and typical plant species from an industrial metropolis in China. Total OUVA concentrations in soils ranged from 1.30 to 80.3 ng g^-1 DW. Based on comparison with previously reported data, OUVA contamination in soil was not severe. Benzophenone and octocrylene were the dominant OUVAs in soils, with median contributions to total concentrations of 25% and 15%, respectively. Source assessment revealed that the observed OUVA contamination primarily originated from industrial activities and the use of personal care products. The concentration of 11 OUVAs in plants ranged from 159 to 4470 ng g^-1 DW, at high levels. Our findings imply that great attention should be given to the presence of these chemicals in plants because of the risk they could pose as well as the potential for biomagnification as plants are eaten by insects and birds. Our results also indicate the necessity to further study the geochemical behavior of these chemicals in urban ecosystems in order to better manage the harmfulness to terrestrial ecological health caused by their exposure through the food chains.

项与奥克立宁相关的新闻（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

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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)	醖構窪鬱選構鏇膚艱窪(窪夢衊簾齋顧憲願襯糧) = 餘簾構簾淵願構餘淵鹽觸齋鹹獵衊艱廠構夢簾 (憲觸繭範窪壓繭獵餘夢, 窪蓋構簾淵艱醖遞築遞 ~ 夢網構構夢壓築膚襯顧) 更多	-	2020-04-21
				Octocrylene+Avobenzone+Oxybenzone (Part 1: Lotion)	醖構窪鬱選構鏇膚艱窪(窪夢衊簾齋顧憲願襯糧) = 窪蓋觸遞淵艱襯憲選壓觸齋鹹獵衊艱廠構夢簾 (憲觸繭範窪壓繭獵餘夢, 遞醖餘糧廠廠願簾鏇淵 ~ 遞糧獵願鹽鹹網製鬱憲) 更多