Evidence map›Paper›PMID 36536093›Full record

Trial reportAesthetic plastic surgery2023

Efficacy and Safety of AbobotulinumtoxinA for the Treatment of Glabellar Lines in Chinese Patients: A Pivotal, Phase 3, Randomized, Double-Blind and Open-Label Phase Study.

Yan Wu, Fang Fang, Wei Lai, Chengxin Li, Li Li, Quanzhong Liu, Jianyun Lu, Xiaowen Pang, Jiaming Sun, Xiaofeng Shi and 4 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Aesthetic plastic surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02450526 (A Phase III, Randomised, Double Blind and Open Label Phase, Multicentre, Active and Placebo Controlled Study to Investigate the Efficacy and Safety of Dysport Including a Comparison to Botox in the Treatment of Moderate to Severe Glabellar Lines, and to Assess the Long Term Efficacy and Safety of Dysport Following Repeated Treatments in This Indication), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02450526 phase3completednot on this map

A Phase III, Randomised, Double Blind and Open Label Phase, Multicentre, Active and Placebo Controlled Study to Investigate the Efficacy and Safety of Dysport Including a Comparison to Botox in the Treatment of Moderate to Severe Glabellar Lines, and to Assess the Long Term Efficacy and Safety of Dysport Following Repeated Treatments in This Indication

TypeinterventionalSponsorIpsenRan2015 to 2017Enrolled520ConditionsGlabellar LinesArmsBotulinum toxin type A, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 3 countries.

Yan WuPeking University First Hospital, No. 8 Xishiku Street, Xicheng, Beijing, 100034, China. 3437477565@qq.com.
Fang FangInstitute of Dermatology, Chinese Academy of Medical Sciences, Nanjing, China.
Wei LaiDepartment of Dermatology, The Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, China.
Chengxin LiGeneral Hospital of People's Liberation Army (301 Hospital), Beijing, China.
Li LiWest China Hospital, Sichuan University, Chengdu, China.
Quanzhong LiuTianjin Medical University General Hospital, Tianjin, China.
Jianyun LuThird Xiangya Hospital of Central South University, Changsha, China.
Xiaowen PangPLA Air Force General Hospital, Beijing, China.
Jiaming SunUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xiaofeng ShiIpsen, Shanghai, China.
Philippe PicautIpsen, Cambridge, MA, USA.
Inna PrygovaIpsen, Boulogne-Billancourt, France.
Bill AndriopoulosGalderma, Uppsala, Sweden.
Qiuning SunPeking Union Medical College Hospital, Beijing, China.
Chinese Academy of Medical Sciences & Peking Union Medical College · CNAir Force General Hospital PLA · CNCentral South University · CNIpsen (France) · FRIpsen (United States) · USPeking University · CNSichuan University · CNSun Yat-sen University · CNTianjin Medical University General Hospital · CNWuhan Union Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVarious botulinumtoxinA formulations are approved for glabellar lines treatment worldwide, including abobotulinumtoxinA (Dysport

objectivesAssess abobotulinumtoxinA superiority versus placebo and non-inferiority versus active comparator (onabotulinumtoxinA; Botox

methodsPhase 3, randomized study (NCT02450526) comprising a double-blind (cycle 1) phase and an open-label (cycles 2-5) phase. Patients received abobotulinumtoxinA 50 units or matching placebo (5:1), active comparator (onabotulinumtoxinA 20 units) or matching placebo (5:1). In cycles 2-5, eligible patients were retreated with abobotulinumtoxinA only. Responders had glabellar lines of none/mild severity. PRIMARY ENDPOINT: responder rates at cycle 1, day 29 at maximum frown with abobotulinumtoxinA versus placebo (for superiority; by investigator's live assessment [ILA] and subject's self-assessment [SSA]), and versus active comparator (for non-inferiority; by ILA). Treatment-emergent adverse events were recorded.

resultsOverall, 520 patients were randomized. Superiority and non-inferiority, respectively, were demonstrated for abobotulinumtoxinA versus placebo (ILA, SSA; both p < 0.0001) and abobotulinumtoxinA versus active comparator. AbobotulinumtoxinA efficacy was maintained over open-label cycles; median time to onset of efficacy was 2.0 days. After 6 months, 17% of patients treated with abobotulinumtoxinA remained responders. AbobotulinumtoxinA was well-tolerated. Safety results were in line with the known profile of abobotulinumtoxinA; adverse events rate decreased with repeated treatment.

conclusionsAfter a single injection, abobotulinumtoxinA demonstrated superiority versus placebo and non-inferiority versus onabotulinumtoxinA for the treatment of moderate-to-severe glabellar lines in Chinese patients. Multiple injections of abobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar lines in Chinese patients. LEVEL OF EVIDENCE I: 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 www.springer.com/00266 .

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsSkin AgingDouble-Blind MethodEast Asian PeopleForeheadHumansTreatment OutcomeabobotulinumtoxinABotulinum Toxins, Type ANeuromuscular Agents

Identifiers

PMID36536093
PMCPMC9944721
OpenAlexW4312020069

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.