{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,31]],"date-time":"2025-10-31T16:53:33Z","timestamp":1761929613155},"reference-count":11,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2012,11,7]],"date-time":"2012-11-07T00:00:00Z","timestamp":1352246400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pediatric Dermatology"],"published-print":{"date-parts":[[2013,5]]},"abstract":"Abstract<\/jats:title>The safety of a novel 0.5% ivermectin lotion (IVL<\/jats:styled-content>) and potential for ivermectin absorption after application was investigated in an open\u2010label study in young children, and a human repeat insult patch test (HRIPT<\/jats:styled-content>) and cumulative irritation test (CIT<\/jats:styled-content>) assessed any potential for cumulative dermal irritation and contact sensitization. In the pharmacokinetic and safety study, 30 head louse\u2013<\/jats:bold>infested children ages 6\u00a0months to 3\u00a0years received a 10\u2010minute application of IVL<\/jats:styled-content> on day 1. Blood was collected before application; 0.5, 1, and 6\u00a0hours after rinsing; and on days 2 and 8. Samples from 20 subjects were assayed for ivermectin (test sensitivity 0.05\u00a0ng\/mL). Liver panel and complete blood counts were completed for all subjects. For the HRIPT<\/jats:styled-content>\/CIT<\/jats:styled-content>, occlusive patches containing IVL<\/jats:styled-content> or vehicle control lotion (CL<\/jats:styled-content>) were repeatedly applied to 220 healthy adult subjects to assess contact sensitization; for cumulative dermal irritation testing, additional patches with normal saline and sodium dodecyl sulfate (SDS<\/jats:styled-content>) were applied to 36 subjects. In the open\u2010label study, all detected ivermectin plasma concentrations were <<\/jats:bold>1\u00a0ng\/mL. No safety signals emerged, and treatment was well tolerated. In the HRIPT<\/jats:styled-content>\/CIT<\/jats:styled-content>, IVL<\/jats:styled-content> was significantly less irritating than normal saline and SDS<\/jats:styled-content>, with no evidence of dermal irritation or sensitization in human skin. IVL<\/jats:styled-content> was safe when applied topically, absorption was de minimus, there was no evidence of irritation or sensitization from repeated exposures, and results support the safety of topical IVL<\/jats:styled-content> use in children as young as 6\u00a0months.<\/jats:p>","DOI":"10.1111\/pde.12033","type":"journal-article","created":{"date-parts":[[2012,11,7]],"date-time":"2012-11-07T10:27:34Z","timestamp":1352284054000},"page":"323-328","source":"Crossref","is-referenced-by-count":8,"title":["Pharmacokinetics and Safety of 0.5% Ivermectin Lotion for Head Louse Infestations"],"prefix":"10.1111","volume":"30","author":[{"given":"Lydie","family":"Hazan","sequence":"first","affiliation":[{"name":"AXIS Clinical Trials Los Angeles California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey E.","family":"Berg","sequence":"additional","affiliation":[{"name":"Hill Top Research St. Petersburg Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James P.","family":"Bowman","sequence":"additional","affiliation":[{"name":"Hill Top Research Miamiville Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John V.","family":"Murray","sequence":"additional","affiliation":[{"name":"Hill Top Research St. Petersburg Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William G.","family":"Ryan","sequence":"additional","affiliation":[{"name":"Ryan Mitchell Associates LLC Westfield New Jersey"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,11,7]]},"reference":[{"key":"e_1_2_5_2_1","doi-asserted-by":"publisher","DOI":"10.1179\/136485908X337418"},{"key":"e_1_2_5_3_1","first-page":"253","article-title":"Efficacy of ivermectin for the treatment of head lice (Pediculosis capitis)","volume":"45","author":"Glaziou P","year":"1994","journal-title":"Trop Med Parasitol"},{"key":"e_1_2_5_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0905471"},{"key":"e_1_2_5_5_1","doi-asserted-by":"crossref","first-page":"991","DOI":"10.1097\/INF.0b013e3181e63f5f","article-title":"Oral ivermectin for treatment of Pediculosis capitis","volume":"29","author":"Ameen M","year":"2010","journal-title":"Pediatr Infect Dis J"},{"key":"e_1_2_5_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1470.2010.01317.x"},{"key":"e_1_2_5_7_1","unstructured":"Ovide (malathion) lotion 0.5%. Prescribing information December 2011. TaroPharma Hawthorne NY."},{"key":"e_1_2_5_8_1","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2010-1308"},{"key":"e_1_2_5_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0536.1977.tb03582.x"},{"key":"e_1_2_5_10_1","doi-asserted-by":"publisher","DOI":"10.3109\/15569528209051516"},{"key":"e_1_2_5_11_1","unstructured":"Stromectol prescribing information May 2010. Marck and Co. Inc. Whitehouse Station NJ."},{"key":"e_1_2_5_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-4632.2004.02253.x"}],"container-title":["Pediatric Dermatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fpde.12033","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pde.12033","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,30]],"date-time":"2023-10-30T21:59:24Z","timestamp":1698703164000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pde.12033"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,11,7]]},"references-count":11,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2013,5]]}},"alternative-id":["10.1111\/pde.12033"],"URL":"https:\/\/doi.org\/10.1111\/pde.12033","archive":["Portico"],"relation":{},"ISSN":["0736-8046","1525-1470"],"issn-type":[{"value":"0736-8046","type":"print"},{"value":"1525-1470","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,11,7]]}}}