Trial reportAesthetic surgery journal2023
Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.
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. It is linked to trial NCT03418545 (A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Correction of Infraorbital Hollowing), which is not on this map. Cited by 6 papers.
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.
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.
A Multicenter, Single-blind, Randomized, Controlled Study of the Safety and Effectiveness of JUVÉDERM VOLBELLA® XC Injectable Gel for Correction of Infraorbital Hollowing
Who cites it
6 citing papers in PubMed.
- Improved Infraorbital Hollowing in Chinese Adults Following Hyaluronic Acid-based Filler With Lidocaine (VYC-15L) Treatment.Aesthetic surgery journal · 2026Trial
- Ultrasound-guided Minimally Invasive Correction of Postblepharoplasty Lower Eyelid Hollowing Using Hyaluronic Acid: A 5-case Series.Plastic and reconstructive surgery. Global open · 2026Article
- Evaluation of the Efficacy and Safety of Injectable Cross-Linked Sodium Hyaluronate Gel Containing Lidocaine for Correcting Infraorbital Hollowing.Aesthetic plastic surgery · 2026Article
- Hyaluronic Acid Fillers Versus Polynucleotides for Under-Eye Rejuvenation.Journal of clinical medicine · 2026Review
- The Treatment of Cosmetic Lower Eyelid Adverse Events After Injection of Hyaluronic Acid Gel Fillers.Aesthetic surgery journal. Open forum · 2024Article
- Multimodal Pilot Evaluation of a Hyaluronic Acid Infraorbital Filler Using Precise, Multipositional, 3-Dimensional Imaging Quantification, Patient-Reported Outcomes, and Anatomic Cadaveric Assessments.Aesthetic surgery journal. Open forum · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
Abstract
backgroundInfraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows.
objectiveThe objective of the current analysis was to examine patient-reported outcomes from the clinical study.
methodsParticipants were randomly assigned 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which patients were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend.
resultsThe modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean [standard deviation], 17.8 [19.8], P < .0001). At Months 3 and 12 posttreatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend.
conclusionsThe current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction based on validated patient-reported outcomes. Participant-assessed improvements aligned with EI-assessed outcomes and lasted for 1 year. LEVEL OF EVIDENCE: 2:
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