{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,28]],"date-time":"2025-08-28T12:48:07Z","timestamp":1756385287228,"version":"3.41.2"},"reference-count":14,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"4","license":[{"start":{"date-parts":[[2021,2,10]],"date-time":"2021-02-10T00:00:00Z","timestamp":1612915200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Dermatol Surg","DS"],"published-print":{"date-parts":[[2021,4]]},"abstract":"<jats:sec>\n            <jats:title>BACKGROUND<\/jats:title>\n            <jats:p>Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not well documented.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>OBJECTIVE<\/jats:title>\n            <jats:p>To evaluate whether prior BoNTA treatment affects efficacy, duration of response, and tolerability for treatment of glabellar lines.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>METHODS<\/jats:title>\n            <jats:p>Adults with moderate or severe glabellar lines treated with DaxibotulinumtoxinA for Injection (DAXI) or placebo from the randomized, double-blind SAKURA 1\/2 trials and the open-label SAKURA 3 safety study were analyzed by prior BoNTA treatment status. Efficacy was evaluated using investigator and participant assessments.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>RESULTS<\/jats:title>\n            <jats:p>In this analysis, 609 participants (52.2% BoNTA-experienced) from the SAKURA 1\/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated. Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups. The incidence of adverse events was also comparable regardless of prior BoNTA treatment status.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>CONCLUSION<\/jats:title>\n            <jats:p>Efficacy and tolerability were similar with DAXI and placebo regardless of prior BoNTA treatment. Assuming an appropriate washout is observed, future BoNTA trials should enroll both treatment-experienced and treatment-naive participants to reflect clinical practice.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/dss.0000000000002877","type":"journal-article","created":{"date-parts":[[2021,2,26]],"date-time":"2021-02-26T11:18:30Z","timestamp":1614338310000},"page":"511-515","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":3,"title":["Prior Botulinum Toxin Treatment Does Not Impact Efficacy or Safety in Clinical Trials: Analysis of DaxibotulinumtoxinA for Injection in the SAKURA Program"],"prefix":"10.1097","volume":"47","author":[{"given":"Joel L.","family":"Cohen","sequence":"first","affiliation":[{"name":"AboutSkin Dermatology and DermSurgery PC, Greenwood Village, Colorado;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lawrence J.","family":"Green","sequence":"additional","affiliation":[{"name":"Department of Dermatology, George Washington University School of Medicine, Washington, District of Columbia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kenneth R.","family":"Beer","sequence":"additional","affiliation":[{"name":"Beer Dermatology, West Palm Beach, Florida;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Liu","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc., Newark, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Conor J.","family":"Gallagher","sequence":"additional","affiliation":[{"name":"Revance Therapeutics, Inc., Newark, California"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","published-online":{"date-parts":[[2021,2,10]]},"reference":[{"key":"R1-20250731","doi-asserted-by":"crossref","first-page":"1089","DOI":"10.1097\/01.PRS.0000076504.79727.62","article-title":"Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines","volume":"112","author":"Carruthers","year":"2003","journal-title":"Plast Reconstr Surg"},{"key":"R2-20250731","doi-asserted-by":"crossref","first-page":"1893","DOI":"10.1111\/j.1524-4725.2009.01235.x","article-title":"Randomized, placebo-controlled study of a new botulinum toxin type a for treatment of glabellar lines: efficacy and safety","volume":"35","author":"Brandt","year":"2009","journal-title":"Dermatol Surg"},{"key":"R3-20250731","first-page":"439","article-title":"The efficacy and safety of a new U.S. Botulinum toxin type A in the retreatment of glabellar lines following open-label treatment","volume":"8","author":"Rubin","year":"2009","journal-title":"J Drugs Dermatol"},{"key":"R4-20250731","doi-asserted-by":"crossref","first-page":"1619","DOI":"10.1097\/PRS.0b013e3181b5641b","article-title":"Evaluation of variable-dose treatment with a new U.S. Botulinum Toxin Type A (Dysport) for correction of moderate to severe glabellar lines: results from a phase III, randomized, double-blind, placebo-controlled study","volume":"124","author":"Kane","year":"2009","journal-title":"Plast Reconstr Surg"},{"key":"R5-20250731","doi-asserted-by":"crossref","first-page":"840","DOI":"10.1067\/mjd.2002.121356","article-title":"A multicenter, double-blind, randomized, placebo-controlled study of the efficacy and safety of botulinum toxin type A in the treatment of glabellar lines","volume":"46","author":"Carruthers","year":"2002","journal-title":"J Am Acad 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a large, open-label, phase 3 safety study","author":"Fabi","year":"2020","journal-title":"Dermatol Surg"},{"key":"R9-20250731","article-title":"A large, open-label, phase 3 safety study of DaxibotulinumtoxinA for Injection in glabellar lines: a focus on safety from the SAKURA 3 study","author":"Green","year":"2020","journal-title":"Dermatol Surg"},{"key":"R10-20250731","doi-asserted-by":"crossref","first-page":"1794","DOI":"10.1111\/j.1524-4725.2012.02582.x","article-title":"OnabotulinumtoxinA: a meta-analysis of duration of effect in the treatment of glabellar lines","volume":"38","author":"Glogau","year":"2012","journal-title":"Dermatol Surg"},{"key":"R15-20250731","doi-asserted-by":"crossref","first-page":"551","DOI":"10.1111\/dsu.12100","article-title":"Multicenter, randomized, phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines","volume":"39","author":"Carruthers","year":"2013","journal-title":"Dermatol Surg"},{"key":"R16-20250731","doi-asserted-by":"crossref","first-page":"1381","DOI":"10.1097\/DSS.0000000000001903","article-title":"Efficacy and safety of PrabotulinumtoxinA for the treatment of glabellar lines in adult subjects: results from 2 identical phase III studies","volume":"45","author":"Beer","year":"2019","journal-title":"Dermatol Surg"},{"key":"R17-20250731","doi-asserted-by":"crossref","first-page":"1382","DOI":"10.1111\/jdv.12881","article-title":"Patient satisfaction after the treatment of glabellar lines with Botulinum toxin type A (Speywood Unit): a multi-centre European observational study","volume":"29","author":"Molina","year":"2015","journal-title":"J Eur Acad Dermatol Venereol"},{"key":"R18-20250731","first-page":"E53","article-title":"IncobotulinumtoxinA for the treatment of glabellar frown lines: a prospective, multicenter, single-arm study in Taiwan","volume":"12","author":"Chao","year":"2019","journal-title":"J Clin Aesthet Dermatol"}],"container-title":["Dermatologic Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.lww.com\/10.1097\/DSS.0000000000002877","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,31]],"date-time":"2025-07-31T22:13:02Z","timestamp":1753999982000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.lww.com\/10.1097\/DSS.0000000000002877"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,2,10]]},"references-count":14,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2021]]}},"URL":"https:\/\/doi.org\/10.1097\/dss.0000000000002877","relation":{},"ISSN":["1076-0512","1524-4725"],"issn-type":[{"type":"print","value":"1076-0512"},{"type":"electronic","value":"1524-4725"}],"subject":[],"published":{"date-parts":[[2021,2,10]]}}}