{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T20:01:30Z","timestamp":1787169690287,"version":"build-2736575974"},"reference-count":37,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2019,8,30]],"date-time":"2019-08-30T00:00:00Z","timestamp":1567123200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background\/objectives<\/jats:title>\n                    <jats:p>Paediatric skin, considered sensitive, and infant skin, more susceptible to percutaneous toxicity, require specially formulated cosmetic products. As recently shown, early use of emollients in infants \u201cat risk\u201d of developing atopic dermatitis has shown controversial results in reducing the incidence of atopic dermatitis. Development of dermo\u2010cosmetic products for this specific population should especially ensure tolerance and safety. In absence of good clinical practice guideline, we propose here a stepwise approach for the development of paediatric cosmetic skincare products.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Our stepwise methodology for cosmetics aimed at paediatrics, starts with\n                      <jats:italic>in vitro<\/jats:italic>\n                      assessment of product's ingredients safety, followed by preclinical and clinical evaluations of the final product, including sequentially: (1) Repeated Open Application Test (ROAT), (2) Human Repeated Insult Patch Test (HRIPT), (3) In\u2010use dermatological and ophthalmological tolerance studies (sequentially in 3a: healthy adults, 3b: healthy paediatric subjects and finally 3c: paediatric patients). We also describe the integrated cosmetovigilance\u2013toxicological surveillance during the clinical development phase and postmarketing.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>As illustrated with one dermo\u2010cosmetic product intended to be used as a preventative\/maintenance treatment for atopic dermatitis in paediatric population, we show that using this stepwise methodology to test a product reduces potential risks of irritation and contact dermatitis in this sensitive population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Standardized ethical stepwise development approach is needed to ensure the commercialization of safe and well\u2010tolerated dermo\u2010cosmetics for paediatrics. The approach described here could potentially serve as guidance for evaluation of new paediatric cosmetic products.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/jdv.15785","type":"journal-article","created":{"date-parts":[[2019,7,9]],"date-time":"2019-07-09T11:24:56Z","timestamp":1562671496000},"page":"2319-2326","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Stepwise approach of development of dermo\u2010cosmetic products in healthy and atopic dermatitis paediatric population: safety evaluation, clinical development and postmarket surveillance"],"prefix":"10.1111","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2132-4517","authenticated-orcid":false,"given":"V.","family":"Ribet","sequence":"first","affiliation":[{"name":"Cosmetovigilance Pierre Fabre Dermo\u2010Cosmetics Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Gurdak","sequence":"additional","affiliation":[{"name":"Research and Development, Clinical Development Division Pierre Fabre Dermo\u2010Cosmetics Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.\u2010J.","family":"Ferret","sequence":"additional","affiliation":[{"name":"Research and Development, Toxicology Division Pierre Fabre Dermo\u2010Cosmetics Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Brinio","sequence":"additional","affiliation":[{"name":"Cosmetovigilance Pierre Fabre Dermo\u2010Cosmetics Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Giordano Labadie","sequence":"additional","affiliation":[{"name":"Department of Dermatology Paul Sabatier University and Larrey Hospital Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.B.","family":"Rossi","sequence":"additional","affiliation":[{"name":"Research and Development, Clinical Development Division Pierre Fabre Dermo\u2010Cosmetics Toulouse France"},{"name":"Department of Dermatology Paul Sabatier University and Larrey Hospital Toulouse France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,8,30]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.1155\/2012\/198789"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.jid.5701239"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/jdv.13636"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1159\/000444805"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11882-014-0433-9"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1470.2011.01308.x"},{"key":"e_1_2_6_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1470.2009.01068.x"},{"key":"e_1_2_6_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0536.2011.01963.x"},{"key":"e_1_2_6_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/cod.12129"},{"key":"e_1_2_6_11_1","unstructured":"Regulation (CE) No 1223\/2009 of the European Parliament and of the council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance).Official Journal of the European Union2009; 59\u2013209."},{"key":"e_1_2_6_12_1","unstructured":"Scientific Committee on Consumer Safety (SCCS) notes of guidance for the testing of cosmetic ingredients and their safety evaluation (9th revision) 9 September 2015 SCCS\/1564\/15 revision of 25 April 2016.2016."},{"key":"e_1_2_6_13_1","unstructured":"Directive 2003\/15\/EC of the European Parliament and of the Council of 27 February 2003 amending Council Directive 76\/768\/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text withEEA relevance).2003."},{"key":"e_1_2_6_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1398-9995.2008.01890.x"},{"key":"e_1_2_6_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13601-019-0257-8"},{"key":"e_1_2_6_16_1","unstructured":"Arr\u00eat\u00e9 du 27 d\u00e9cembre 1999 relatif aux m\u00e9thodes officielles d'analyse n\u00e9cessaires aux contr\u00f4les de la composition des produits cosm\u00e9tiques. 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