{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T06:19:22Z","timestamp":1790662762084,"version":"4.1.0"},"reference-count":28,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2014,3,8]],"date-time":"2014-03-08T00:00:00Z","timestamp":1394236800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"funder":[{"DOI":"10.13039\/501100000801","name":"Bayer Healthcare","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100000801","id-type":"DOI","asserted-by":"publisher"}]},{"name":"KYTHERA Biopharmaceuticals Inc."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2014,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Unwanted submental fat (<jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content>) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non\u2010surgical method for <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> reduction is lacking.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of <jats:styled-content style=\"fixed-case\">ATX<\/jats:styled-content>\u2010101 for the pharmacological reduction of unwanted <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> in a phase <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content> randomized, double\u2010blind, placebo\u2010controlled study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients (<jats:italic>n<\/jats:italic>\u00a0=\u00a0360) with moderate or severe <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> were randomized to receive <jats:styled-content style=\"fixed-case\">ATX<\/jats:styled-content>\u2010101 1 or 2\u00a0mg\/cm<jats:sup>2<\/jats:sup> or placebo injected into their <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> for up to four treatments ~28\u00a0days apart, with a 12\u2010week follow\u2010up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a \u22651\u2010point reduction in <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> on the Clinician\u2010Reported Submental Fat Rating Scale (<jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">SMFRS<\/jats:styled-content>), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self\u2010Rating Scale (<jats:styled-content style=\"fixed-case\">SSRS<\/jats:styled-content> score \u22654). Secondary efficacy endpoints included a \u22651\u2010point improvement in <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> on the Patient\u2010Reported Submental Fat Rating Scale (<jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">SMFRS<\/jats:styled-content>) and changes in the Patient\u2010Reported Submental Fat Impact Scale (<jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">SMFIS<\/jats:styled-content>). Additional patient\u2010reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Compared with placebo, a greater proportion of patients treated with <jats:styled-content style=\"fixed-case\">ATX<\/jats:styled-content>\u2010101 1 and 2\u00a0mg\/cm<jats:sup>2<\/jats:sup> showed a \u22651\u2010point improvement in <jats:styled-content style=\"fixed-case\">CR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">SMFRS<\/jats:styled-content> (58.3% and 62.3%, respectively, vs. 34.5% with placebo; <jats:italic>P\u00a0<\/jats:italic>&lt;\u00a00.001) and patient satisfaction (<jats:styled-content style=\"fixed-case\">SSRS<\/jats:styled-content> score \u22654) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001). Patient\u2010reported secondary efficacy endpoints showed significant improvements in <jats:styled-content style=\"fixed-case\">SMF<\/jats:styled-content> severity (<jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">SMFRS<\/jats:styled-content>;<jats:italic> P\u00a0<\/jats:italic>=\u00a00.009 for <jats:styled-content style=\"fixed-case\">ATX<\/jats:styled-content>\u2010101 1\u00a0mg\/cm<jats:sup>2<\/jats:sup>, <jats:italic>P\u00a0<\/jats:italic>&lt;\u00a00.001 for <jats:styled-content style=\"fixed-case\">ATX<\/jats:styled-content>\u2010101 2\u00a0mg\/cm<jats:sup>2<\/jats:sup> vs. placebo) and emotions and perceived self\u2010image (<jats:styled-content style=\"fixed-case\">PR<\/jats:styled-content>\u2010<jats:styled-content style=\"fixed-case\">SMFIS<\/jats:styled-content>;<jats:italic> P\u00a0<\/jats:italic>&lt;\u00a00.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p><jats:styled-content style=\"fixed-case\">ATX<\/jats:styled-content>\u2010101 was effective and well tolerated, and may be an alternative to surgery for patients desiring improvement of their submental profile.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.12377","type":"journal-article","created":{"date-parts":[[2014,3,8]],"date-time":"2014-03-08T10:24:04Z","timestamp":1394274244000},"page":"1707-1715","source":"Crossref","is-referenced-by-count":117,"title":["Efficacy, patient\u2010reported outcomes and safety profile of <scp>ATX<\/scp>\u2010101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase <scp>III<\/scp>, randomized, placebo\u2010controlled study"],"prefix":"10.1111","volume":"28","author":[{"given":"B.","family":"Ascher","sequence":"first","affiliation":[{"name":"Clinic of Aesthetic Surgery IENA Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Hoffmann","sequence":"additional","affiliation":[{"name":"Department of Dermatology Ruhr University Bochum Bochum Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Walker","sequence":"additional","affiliation":[{"name":"KYTHERA Biopharmaceuticals Inc. 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