Evidence map›Paper›PMID 36087303›Full record

Trial reportAesthetic surgery journal2023

Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials.

Nowell Solish, Cheryl M Burgess, Susan H Weinkle, Glynis Ablon, Jessica Brown, Kristie Kooken, Roman G Rubio

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Aesthetic surgery journal, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 21% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 2 countries.

Nowell SolishDivision of Dermatology, University of Toronto, ON, Canada.
Cheryl M BurgessCenter for Dermatology and Dermatologic Surgery, Washington, DC, USA.
Susan H WeinkleUniversity of South Florida, Tampa, FL, USA.
Glynis AblonUniversity of California Los Angeles (UCLA), Los Angeles, CA, USA.
Jessica BrownRevance Therapeutics, Inc., Nashville, TN, USA.
Kristie KookenRevance Therapeutics, Inc., Nashville, TN, USA.
Roman G RubioBlue Obsidian Consulting LLC, Redwood City, CA, USA.
University of California, Los Angeles · USUniversity of South Florida · USUniversity of Toronto · CAWashington Institute of Dermatologic Laser Surgery · US

Funding

Revance Therapeutics, Inc
6 · The paper itself

Abstract

backgroundDaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation approved for the treatment of glabellar lines. The efficacy, safety, and extended duration of response of DAXI 40 U for glabellar lines were demonstrated in 2 Phase 3, randomized, double-blind studies (SAKURA 1 and 2) and a Phase 3 open-label trial (SAKURA 3).

objectivesThe aim of this study was to evaluate the efficacy and safety of the first DAXI 40 U treatment received in SAKURA 1, 2, or 3 across age and race subgroups.

methodsAdults with moderate-to-severe glabellar lines (Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] and Patient FWS [PFWS] scales) were evaluated for glabellar line severity for ≤36 weeks after the first DAXI treatment. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black and African American, and White).

resultsOverall, 2785 patients were included in the efficacy analysis. The proportion of patients achieving none or mild glabellar line severity at maximum frown (IGA-FWS) after DAXI treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and PFWS rating was maintained for a median of 24.0 weeks in all age subgroups, and for 27.0, 25.3, and 24.0 weeks in the Asian, Black and African American, and White subgroups, respectively. Treatment-emergent adverse events were similar across all subgroups.

conclusionsConsistent with the overall study population, DAXI 40 U demonstrated a high response rate and duration of effect of ≥24 weeks across all age and race subgroups.

Indexed as

Botulinum Toxins, Type ANeuromuscular AgentsSkin AgingAdultDouble-Blind MethodForeheadHumansImmunoglobulin AInjectionsMiddle AgedTreatment OutcomeBotulinum Toxins, Type AImmunoglobulin ANeuromuscular Agents

Identifiers

PMID36087303
PMCPMC9896135
OpenAlexW4295107463

What OpenQuestion holds

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Registered trials

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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.