{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T13:04:32Z","timestamp":1792069472632,"version":"4.4.0"},"reference-count":14,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2024,10,14]],"date-time":"2024-10-14T00:00:00Z","timestamp":1728864000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,10,14]],"date-time":"2024-10-14T00:00:00Z","timestamp":1728864000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Laboratoires VIVACY"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Aesth Plast Surg"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>Hyaluronic acid (HA) is a widely used dermal filler for lip augmentation. IPN-20-SENSE LIDOCAINE (Laboratoires VIVACY) is a monophasic gel consisting of cross-linked HA and includes lidocaine hydrochloride for the reduction of injection-associated pain.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Aims<\/jats:title>\n            <jats:p>The SMILE study was designed to assess the non-inferiority of IPN-20-SENSE LIDOCAINE compared to HA-RK-Lido in improving aesthetic lip appearance. The secondary objectives were to evaluate the effectiveness and safety of IPN-20-SENSE LIDOCAINE against the chosen similar active control device.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Patients\/Methods<\/jats:title>\n            <jats:p>This was a prospective, multicenter, double-blinded, randomized active controlled parallel group study undertaken in two investigational sites between May 2021 and July 2022 (14 months). The primary endpoint of this study was the proportion of subjects reporting an improvement on the Global Aesthetic Improvement Scale (GAIS) 3 months after treatment initiation.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Regarding the primary endpoint, the difference between the treatment arms in the proportion of improved subjects was +7.0\u00a0[-2.2;\u00a017.7]. The lower limit of this 90%\u00a0CI, being above the non-inferiority margin of -15 and below zero, demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE vs. HA-RK-Lido. The secondary outcomes reported by subjects and the blinded live evaluators supported this result. All injection site reactions and device-related adverse events reported in this study were expected, already described and were mostly mild and transient.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>The study demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE to HA-RK-Lido in the aesthetic improvement of the lips. The effect of both treatments decreased over time. Nonetheless, aesthetic improvement was sustained longer in the IPN-20-SENSE LIDOCAINE arm.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Level of Evidence I<\/jats:title>\n            <jats:p>This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/www.springer.com\/00266\" ext-link-type=\"uri\">www.springer.com\/00266<\/jats:ext-link>.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s00266-024-04398-z","type":"journal-article","created":{"date-parts":[[2024,10,14]],"date-time":"2024-10-14T20:23:47Z","timestamp":1728937427000},"page":"1033-1045","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Effectiveness and Safety of IPN-20-SENSE LIDOCAINE for Lip Volume Augmentation and\/or Redefinition (SMILE Study): A Non-inferiority Randomized Double-Blinded Controlled Study"],"prefix":"10.1007","volume":"49","author":[{"given":"Nicolas","family":"Froget","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Izabela","family":"Kobyli\u0144ska","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Warszawik-Hendzel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Guidicelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-2602-991X","authenticated-orcid":false,"given":"Julia","family":"Gotlib","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,10,14]]},"reference":[{"key":"4398_CR1","doi-asserted-by":"publisher","first-page":"601","DOI":"10.1016\/j.cps.2018.06.008","volume":"45","author":"C Winslow","year":"2018","unstructured":"Winslow C (2018) Surgical and nonsurgical perioral\/lip rejuvenation. 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Nicolas Froget, Izabela Kobyli\u0144ska, Olga Warszawik-Hendzel, Thomas Guidicelli and Julia Gotlib have no conflict of interest to declare. All authors received honoraria from Laboratoires VIVACY for their participation in this study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The authors confirm that the ethical policies of the journal, as noted on the journal\u2019s author guidelines page, have been adhered to and the appropriate ethical approvals have been received. The study received favorable ethical approval in each of the participating countries prior to commencement (France: Committee for the Protection of Persons [Comit\u00e9 de Protection des Personnes\u2013CPP] Est I, approved on 11th March 2021, N\u00b0 SI 21.01.22.75713. Poland: Bioethics Committee of the Regional Chamber of Physicians in\u00a0Gdansk, 23rd February 2021, KB - 888 \/ 2021 \/ 23.02.2021). The SMILE study was registered at the Agence Nationale de S\u00e9curit\u00e9 des M\u00e9dicaments et des produits de sant\u00e9 (ANSM) (ANSM: 2021-A00089-32) and ClinicalTrials.gov prior to starting recruitment (ClinicalTrials.gov: NCT04813614). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}},{"value":"The authors confirm that subjects were aware of and agreed for their photos to be taken. Any photos used in this manuscript had the subject\u2019s prior awareness and approval to be used and published for this purpose.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed Consent"}}]}}