{"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":1783734386075,"version":"3.55.0"},"reference-count":10,"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":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"EV-004 study, Evolus, Inc"}],"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 assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U\/0.1 mL freeze-dried formulation injected into 5 target 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 was evaluated throughout the study.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit.<\/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 first established in this early 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\/sjaa383","type":"journal-article","created":{"date-parts":[[2021,5,4]],"date-time":"2021-05-04T15:21:06Z","timestamp":1620141666000},"page":"1409-1422","source":"Crossref","is-referenced-by-count":9,"title":["The First 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":"Joely","family":"Kaufman-Janette","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rui L","family":"Avelar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian S","family":"Biesman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zoe Diana","family":"Draelos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John E","family":"Gross","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek H","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mary P","family":"Lupo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corey S","family":"Maas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Schlessinger","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ava Teresa","family":"Shamban","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hema","family":"Sundaram","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan H","family":"Weinkle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vernon L","family":"Young","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,5,4]]},"reference":[{"issue":"2","key":"2021111720095841900_CIT0001","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1111\/ijd.12627","article-title":"Comparative trial of a novel botulinum neurotoxin type A versus onabotulinumtoxinA in the treatment of glabellar lines: a multicenter, randomized, double-blind, active-controlled study","volume":"54","author":"Won","year":"2015","journal-title":"Int J Dermatol"},{"issue":"11","key":"2021111720095841900_CIT0002","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":"2021111720095841900_CIT0003","article-title":"The second 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":"Lorenc","journal-title":"Aesthet Surg J"},{"key":"2021111720095841900_CIT0004","volume-title":"Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for industry. Upper facial lines: developing botulinum toxin drug products. Draft guidance","author":"U.S. Department of Health and Human Services","year":"2014"},{"issue":"7","key":"2021111720095841900_CIT0005","doi-asserted-by":"crossref","first-page":"1186","DOI":"10.1212\/01.WNL.0000055087.96356.BB","article-title":"Comparison of efficacy and immunogenicity of original versus current botulinum toxin in cervical dystonia","volume":"60","author":"Jankovic","year":"2003","journal-title":"Neurology"},{"key":"2021111720095841900_CIT0006","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":"2021111720095841900_CIT0007","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":"2021111720095841900_CIT0008","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":"2021111720095841900_CIT0009","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":"2021111720095841900_CIT0010","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"}],"container-title":["Aesthetic Surgery Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/asj\/article-pdf\/41\/12\/1409\/41135613\/sjaa383.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/asj\/article-pdf\/41\/12\/1409\/41135613\/sjaa383.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,11,17]],"date-time":"2021-11-17T20:18:49Z","timestamp":1637180329000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/asj\/article\/41\/12\/1409\/6263932"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,4]]},"references-count":10,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2021,5,4]]},"published-print":{"date-parts":[[2021,11,12]]}},"URL":"https:\/\/doi.org\/10.1093\/asj\/sjaa383","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":[[2021,5,4]]}}}