{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T01:53:17Z","timestamp":1782179597695,"version":"3.54.5"},"reference-count":11,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2018,4,15]],"date-time":"2018-04-15T00:00:00Z","timestamp":1523750400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","award":["RH01864"],"award-info":[{"award-number":["RH01864"]}],"id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J of Cosmetic Dermatology"],"published-print":{"date-parts":[[2019,2]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>New cosmetic products should undergo clinical evaluation for skin sensitization potential.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To assess the irritation and sensitization potential of a moisturizer containing lamellar structured lipids after repeated patch application in humans, using human repeated insult patch test methodology.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This 6\u2010week, single\u2010center, open\u2010label study compared a lamellar moisturizer with negative saline control in human subjects aged 18\u201070\u00a0years and skin phototype (Fitzpatrick) classification I\u2013<jats:styled-content style=\"fixed-case\">IV<\/jats:styled-content>. During an initial induction phase, semi\u2010occlusive multi\u2010test patches were applied to the skin of participants\u2019 backs three times per week for 3 consecutive weeks; clinical assessments were performed per International Contact Dermatitis Research Group criteria. Participants subsequently underwent a challenge phase, where a new patch was applied to a contact\u2010na\u00efve area of the skin to assess sensitization to the moisturizer.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study commenced with 233 voluntary participants, 214 of whom completed the study and underwent the final dermatological assessment. Most participants (232\/233; 99.6%) demonstrated negative patch test results. One participant had a positive reaction at the lamellar moisturizer application site, with visible erythema and edema (classified as an adverse event [<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>]); however, this reaction was observed 24\u00a0hours after a reaction to another product in the patch test panel (a prototype cleanser). Importantly, no skin reactions were detected during the challenge phase. Two participants had <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s of mild contact dermatitis in the area of patch adhesive application during the induction phase. No serious <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s occurred during the study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>These findings suggest that the lamellar moisturizer has low irritant and allergenic potential.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jocd.12535","type":"journal-article","created":{"date-parts":[[2018,4,15]],"date-time":"2018-04-15T17:30:04Z","timestamp":1523813404000},"page":"377-382","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Absence of human skin irritation and allergenic potential after repeated patch applications of a lamellar moisturizer"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7209-9586","authenticated-orcid":false,"given":"Stephanie J","family":"Nisbet","sequence":"first","affiliation":[{"name":"GSK Consumer Healthcare St George's Avenue Weybridge Surrey UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,4,15]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"McKoyK.Definition of Dermatitis. Merck Manual.2014.https:\/\/www.merckmanuals.com\/professional\/dermatologic-disorders\/dermatitis. Accessed January 26 2017."},{"key":"e_1_2_7_3_1","first-page":"41","volume-title":"Current Concepts in Cutaneous Toxicity","author":"Stotts J","year":"1980"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1080\/15569520902938032"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/toxsci\/59.2.198"},{"key":"e_1_2_7_6_1","unstructured":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use: Guideline for Good Clinical Practice E6(R1).1996.http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E6\/E6_R1_Guideline.pdf. Accessed October 5 2016."},{"key":"e_1_2_7_7_1","unstructured":"World Medical Association.Declaration of Helsinki \u2013 Ethical Principles for Medical Research Including Human Subjects.2008.http:\/\/www.wma.net\/en\/30publications\/10policies\/b3\/. 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