Evidence map›Paper›PMID 37439274›Full record

ArticleAesthetic surgery journal2024

Long-term Performance and Safety of Princess VOLUME PLUS Lidocaine for Midface Augmentation: The PRIMAvera Clinical Study.

Berthold Rzany, Monika Sulovsky, Gerhard Sattler, Michael Cecerle, Doris Grablowitz

Erratum issuedOpen access · hybridAbstract readMulticenter Study
In one paragraph

Article in Aesthetic surgery journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. A Review: Causes, Consequences, and Management Strategies of Facial Overfilling.Clinical, cosmetic and investigational dermatology · 2025
    Review
  5. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Berthold Rzany
Monika Sulovsky
Gerhard Sattler
Michael Cecerle
Doris Grablowitz
Croma Pharma (Austria) · AT

Funding

Croma Pharma GmbH
6 · The paper itself

Abstract

backgroundHyaluronic acid-based dermal fillers are the most applied medical devices for midface augmentation.

objectivesThis postmarket investigation evaluated the long-term performance and safety of and patient satisfaction with Princess VOLUME PLUS Lidocaine (PVPL; now Saypha VOLUME PLUS Lidocaine) for the correction of midface volume deficit (MVD).

methodsThis was an open-label, prospective, interventional, multicenter, noncomparative, postapproval study of 91 patients with moderate or severe MVD (grade 2 or 3 on the 5-point Midface Volume Deficit Severity Scale, or MVDSS). At Day 0 (Visit 1), patients were treated with PVPL; they returned for follow-up assessments at weeks 2, 4, 12, 24, 36, and 52 and had long-term follow-up until 36 months. A touch-up treatment could be done at week 2. The performance was assessed with the MVDSS, Global Aesthetic Improvement Scale (GAIS), and a subject satisfaction scale. Adverse events were collected to assess safety throughout the study.

resultsFour weeks after treatment, 100% of injected patients improved by ≥1 grade on the MVDSS compared to baseline, with improvements still visible in 77% of patients 52 weeks after treatment. Based on the GAIS and post hoc survival analysis, the treatment effect was maintained for a median of 386 days, and in severe cases the effect lasted longer, which seemed to be independent of the volume injected at baseline. No serious side effects were reported. Results were substantiated by high patient satisfaction.

conclusionsPrincess VOLUME PLUS Lidocaine was perceived as safe and effective by patients and investigators, with long-term aesthetic improvement in moderate and severe cases. LEVEL OF EVIDENCE: 3:

Indexed as

Cosmetic TechniquesDermal FillersSkin AgingHumansHyaluronic AcidLidocainePatient SatisfactionProspective StudiesTreatment OutcomeDermal FillersHyaluronic AcidLidocaine

Identifiers

PMID37439274
PMCPMC10790962
OpenAlexW4384106387

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.