{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T01:46:26Z","timestamp":1783734386804,"version":"3.55.0"},"reference-count":12,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T00:00:00Z","timestamp":1620086400000},"content-version":"vor","delay-in-days":1,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"EV-006 study"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,11,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0\u2005=\u2005no lines, 1\u2005=\u2005mild, 2\u2005=\u2005moderate, 3\u2005=\u2005severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U\/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was \u22652 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug\u2013related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug\u2013related AEs. Eight patients (1.4%) experienced study drug\u2013related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Level of Evidence: 2<\/jats:title>\n                  <jats:p\/>\n               <\/jats:sec>","DOI":"10.1093\/asj\/sjaa382","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T15:21:13Z","timestamp":1620141673000},"page":"1423-1438","source":"Crossref","is-referenced-by-count":10,"title":["The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients"],"prefix":"10.1093","volume":"41","author":[{"given":"Z Paul","family":"Lorenc","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey M","family":"Adelglass","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui L","family":"Avelar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Baumann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth R","family":"Beer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel L","family":"Cohen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sue 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H","family":"Joseph","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joely","family":"Kaufman-Janette","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald L","family":"Moy","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Nestor","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Schlessinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacy R","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert 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Upper Facial Lines: Developing Botulinum Toxin Drug Products. Draft Guidance","author":"U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER)","year":"2014"},{"key":"2021111720094177200_CIT0005","first-page":"63","article-title":"One-year, randomised, multicenter, two-period study of the safety and efficacy of repeated treatments with botulinum toxin type A in patients with glabellar lines","volume":"7","author":"Carruthers","year":"2004","journal-title":"J Drug Assessment"},{"issue":"1 Spec No","key":"2021111720094177200_CIT0006","doi-asserted-by":"crossref","first-page":"S18","DOI":"10.1111\/j.1524-4725.2006.32327.x","article-title":"Repeated botulinum toxin A injections for the treatment of lines in the upper face: a retrospective study of 4,103 treatments in 945 patients","volume":"33","author":"Rzany","year":"2007","journal-title":"Dermatol Surg"},{"issue":"5","key":"2021111720094177200_CIT0007","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"},{"issue":"2","key":"2021111720094177200_CIT0008","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1001\/archfaci.2009.5","article-title":"Long-term safety and efficacy of a new botulinum toxin type A in treating glabellar lines","volume":"11","author":"Moy","year":"2009","journal-title":"Arch Facial Plast Surg"},{"issue":"1 Pt 1","key":"2021111720094177200_CIT0009","doi-asserted-by":"crossref","first-page":"95","DOI":"10.1111\/dsu.12008","article-title":"Long-term results for incobotulinumtoxinA in the treatment of glabellar frown lines","volume":"39","author":"Rzany","year":"2013","journal-title":"Dermatol Surg"},{"key":"2021111720094177200_CIT0010","article-title":"The first of two 1-year, multicenter, open-label, repeat-dose, phase II safety studies of prabotulinumtoxinA for the treatment of moderate to severe glabellar lines in adult patients","author":"Kaufman-Janette","journal-title":"Aesthet Surg J"},{"key":"2021111720094177200_CIT0011","author":"American Society of Plastic Surgeons"},{"key":"2021111720094177200_CIT0012","author":"The Aesthetic Society's Cosmetic Surgery"}],"container-title":["Aesthetic Surgery Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/asj\/article-pdf\/41\/12\/1423\/41135527\/sjaa382.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/asj\/article-pdf\/41\/12\/1423\/41135527\/sjaa382.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,11,17]],"date-time":"2021-11-17T20:17:53Z","timestamp":1637180273000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/asj\/article\/41\/12\/1423\/6263929"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,3]]},"references-count":12,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2021,5,3]]},"published-print":{"date-parts":[[2021,11,12]]}},"URL":"https:\/\/doi.org\/10.1093\/asj\/sjaa382","relation":{},"ISSN":["1090-820X","1527-330X"],"issn-type":[{"value":"1090-820X","type":"print"},{"value":"1527-330X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2021,12,1]]},"published":{"date-parts":[[2021,5,3]]}}}