Evidence map›Paper›PMID 38573527›Full record

Trial reportAesthetic surgery journal2024

A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

Brian S Biesman, Jeremy B Green, Rosalyn George, Carolyn Jacob, Melanie Palm, Derek H Jones, Lisa Grunebaum, Kenneth Beer, Young Cho, John H Joseph and 3 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Aesthetic surgery journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.7field-weighted citation impact, top 11% 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, 5 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
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

13 authors at 7 institutions in 1 country.

Brian S Biesman
Jeremy B Green
Rosalyn George
Carolyn Jacob
Melanie Palm
Derek H Jones
Lisa Grunebaum
Kenneth Beer
Young Cho
John H Joseph
Birgitta Almegård
Felipe Weinberg
Torun Bromée
Clinical Research of South Florida · USEncino Hospital Medical Center · USGalderma (United States) · USPalm Beach Neurology · USVanderbilt University Medical Center · USWilmington University · USWinnMed · US

Funding

GaldermaGalderma Research and DevelopmentLLC
6 · The paper itself

Abstract

backgroundHyaluronic acid injections are increasingly administered for correction of infraorbital hollows (IOHs).

objectivesThe objective of this study was to examine the effectiveness (IOH correction) and safety of Restylane Eyelight hyaluronic acid (HAEYE) injections.

methodsPatients with moderate/severe IOHs, assessed with the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (by needle/cannula) (Day 1 + optional Month 1 touch-up) or no-treatment control. The primary endpoint was blinded evaluator-reported Month 3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement on the Global Aesthetic Improvement Scale (GAIS), patient-reported satisfaction (FACE-Q satisfaction with outcome; satisfaction questionnaire), and adverse events.

resultsOverall, 333 patients were randomized. Month 3 GIHS responder rate was significantly higher for HA-EYE (87.4%) vs control (17.7%; P < .001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (P = .967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) vs 14.1-16.2 (control) through Month 12. Patients reported looking younger (≥71%) and less tired (≥79%) with reduced undereye shadows (≥76%) and recovered within 3-5 hours posttreatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month 12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores 72.5-72.8). Forty patients (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula).

conclusionsHAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after 1 retreatment) with needle or cannula administration. Safety outcomes were reassuring. LEVEL OF EVIDENCE: 1:

Indexed as

Cosmetic TechniquesDermal FillersHyaluronic AcidPatient SatisfactionAdultAgedEstheticsFemaleHumansMaleMiddle AgedSingle-Blind MethodTreatment OutcomeYoung AdultDermal FillersHyaluronic AcidRestylane

Identifiers

PMID38573527
PMCPMC11334209
OpenAlexW4393996350

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.