{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T15:01:28Z","timestamp":1761490888605,"version":"3.37.3"},"reference-count":45,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2019,10,18]],"date-time":"2019-10-18T00:00:00Z","timestamp":1571356800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2019,10,18]],"date-time":"2019-10-18T00:00:00Z","timestamp":1571356800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Pohl-Boskamp GmbH & Co. KG","award":["n\/a"],"award-info":[{"award-number":["n\/a"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Dermatol"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n              <jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Increasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10\u2009min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10\u2009min) or reference products (45\u2009min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>After 10\u2009min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients\u2019 compliance.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>EU Clinical Trials Register EudraCT\u00a0<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=eudract_number%3A2016-004635-20\">2016\u2013004635-20<\/jats:ext-link>. Registered 14 November 2016.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12895-019-0094-4","type":"journal-article","created":{"date-parts":[[2019,10,23]],"date-time":"2019-10-23T10:57:02Z","timestamp":1571828222000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial"],"prefix":"10.1186","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7845-5510","authenticated-orcid":false,"given":"Jorg","family":"Heukelbach","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Doerte","family":"Wolf","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John Marshall","family":"Clark","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans","family":"Dautel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristina","family":"Roeschmann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2019,10,18]]},"reference":[{"key":"94_CR1","doi-asserted-by":"publisher","first-page":"152","DOI":"10.2471\/BLT.07.047308","volume":"87","author":"H Feldmeier","year":"2009","unstructured":"Feldmeier H, Heukelbach J. 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All participants were undertaken an informed consent procedure and signed the informed consent form (ICF). As children that participated in this study were unable to provide legally binding consent, the legal representative\/s of all minor participants had to give informed written consent on his\/her behalf prior to enrolment in the trial, and after having been informed about all details concerning the trial (patient information and informed consent from). Furthermore, age appropriate consent forms were used for children aged 7\u201311\u2009year, and adolescents aged 12\u201317\u2009years. All minors included in this trial provided written or verbal assent, according to age, witnessed by the parent or guardian.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"KR is an employee of Pohl-Boskamp and was involved in drafting the manuscript, revising it critically for important intellectual content, ensuring that questions related to accuracy and integrity of the work are resolved. Pohl-Boskamp engaged the CRO CardioSec Clinical Research GmbH to design and perform the clinical trial. Principle investigator was DW, who is managing director of CardioSec Clinical Research. Pohl-Boskamp provided salaries to JC and HD on a work-for-hire basis and remunerated the CRO CardioSec Clinical Research GmbH for their services in performing the study. DW is a company member of CardioSec Clinical Research GmbH without any financial or personal interest in the test product. JH has been an independent scientific consultant to Pohl-Boskamp GmbH & Co. KG.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"14"}}