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Record W4394951517 · doi:10.1097/prs.0000000000011472

Efficacy and Safety of OnabotulinumtoxinA for the Treatment of Platysma Prominence: A Randomized Phase 2 Dose-Ranging Study

2024· article· en· W4394951517 on OpenAlexaff
Rod J. Rohrich, Vince Bertucci, Steven Dayan, Derek Jones, Nowell Solish, Jason K. Rivers, Channy Muhn, Christy Harutunian, Grace S. Park, Sandhya Shimoga, Elisabeth Lee, Warren Tong

Bibliographic record

VenuePlastic & Reconstructive Surgery · 2024
Typearticle
Languageen
FieldMedicine
TopicBotulinum Toxin and Related Neurological Disorders
Canadian institutionsSKiN HealthUniversity of British ColumbiaUniversity of Toronto
FundersAllerganAmerican Academy of Dermatology
KeywordsDose-ranging studyRangingPhase (matter)MedicineGeographyPhysicsGeodesyDouble blindAlternative medicine

Abstract

fetched live from OpenAlex

BACKGROUND: With aging, repetitive contraction of the platysma leads to an increase in platysma prominence (PP), characterized by the accentuation of vertical neck bands and blunting of the jawline contour. METHODS: This multicenter, double-blind, phase 2 study evaluated onabotulinumtoxinA treatment in adults with moderate to severe PP. Participants were randomized to receive 1 treatment of onabotulinumtoxinA low dose (LD), onabotulinumtoxinA high dose (HD), or placebo, and were followed up for 4 months. Efficacy end points were achievement of a 1 grade or greater improvement on both the left and right sides at day 14 at maximum contraction as assessed by the investigator (primary) or by participants (secondary) using validated scales. Safety was evaluated throughout. RESULTS: Participants in the modified intent-to-treat population ( n = 164) had a mean age of 50 years; 95.1% were women and 93.9% were White. The primary end point was met for both onabotulinumtoxinA groups, with investigator-assessed 1 grade or greater improvement in 77.8% (LD) and 88.2% (HD) versus 12.0% (placebo) of participants on day 14 ( P < 0.0001 versus placebo). Based on participant self-assessment, 75.9% (LD) and 88.2% (HD) versus 18.0% (placebo) achieved 1 grade or greater improvement on day 14 ( P < 0.0001 versus placebo). Most treatment-related adverse events were procedure-related, transient, and mild in severity. The most frequent onabotulinumtoxinA-related adverse event was neck muscle weakness, reported in the HD group. CONCLUSION: OnabotulinumtoxinA was effective in improving the appearance of PP based on both investigators' and participants' ratings. Treatment was well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.475
Threshold uncertainty score0.489

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.001
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.028
GPT teacher head0.301
Teacher spread0.273 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations10
Published2024
Admission routes1
Has abstractyes

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