Trial reportAesthetic surgery journal2021
A Prospective, Multicenter, Single-Blind, Randomized, Controlled Study of VYC-15L, a Hyaluronic Acid Filler, in Adults for Correction of Infraorbital Hollowing.
Trial report in Aesthetic surgery journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06828237 (Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of Moderate or Severe Infraorbital Hollowing), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled 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.
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.
Open, Non-comparative Study to Evaluate the Effectiveness and Safety of the Medical Device KOS® S in the Correction of Moderate or Severe Infraorbital Hollowing
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Safety and Potential Complications of Facial Wrinkle Correction with Dermal Fillers: A Systematic Literature Review.Medicina (Kaunas, Lithuania) · 2024Pooled it
- Improved Infraorbital Hollowing in Chinese Adults Following Hyaluronic Acid-based Filler With Lidocaine (VYC-15L) Treatment.Aesthetic surgery journal · 2026Trial
- A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.Aesthetic surgery journal · 2024Trial
- Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.Aesthetic surgery journal · 2023Trial
- BB8 Technique: An Innovative Approach for Delivering Diluted Belotero® Balance to Treat Infraorbital Hollows.Cureus · 2026Article
- Adverse reactions and complications caused by hyaluronic acid injections in the face: A scoping review.Brazilian dental journal · 2026Article
- Complications of Periorbital Cosmetic Hyaluronic Acid Filler Injections: A Major ReviewTurkish journal of ophthalmology · 2025Review
- Improved Periorbital Satisfaction After Combined Mid and Upper Facial Treatment With Hyaluronic Acid Fillers and OnabotulinumtoxinA: Effectiveness and Safety Results From a Post-Marketing Study.Journal of cosmetic dermatology · 2025Article
- Optimizing Infraorbital Hollows Treatment With Hyaluronic Acid Fillers: Overview of Anatomy, Injection Techniques, and Product Considerations.Aesthetic surgery journal. Open forum · 2025Review
- 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
- Infraorbital Hollow Rejuvenation: Considerations, Complications, and the Contributions of Midface Volumization.Aesthetic surgery journal. Open forum · 2023Review
- Validating the Reliability and Clinical Relevance of an Infraorbital Hollow Photonumeric Scale.Aesthetic surgery journal. Open forum · 2023Article
- Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study.Clinical, cosmetic and investigational dermatology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundRejuvenation of the under-eye area is a popular facial aesthetic treatment option.
objectivesThis study evaluated the safety and effectiveness of VYC-15L for the correction of moderate or severe infraorbital hollowing.
methodsThis was a randomized, controlled, single-blind study with a primary endpoint defined as the proportion of participants with ≥1-grade improvement at Month 3 assessed by an evaluating investigator employing the Allergan Infraorbital Hollow Scale. Three-dimensional imaging was conducted to assess infraorbital volume up to Month 12. Procedure pain and injection-site responses (ISRs) were documented, and safety was monitored throughout the study.
resultsAt Month 3, the difference between treatment (83.1%) and control (15.6%) was 67.5% (95% CI = 52.9 to 82.0, P < 0.0001). 3D imaging showed a mean volume increase from baseline of 0.733 mL (left) and 0.777 mL (right) at Month 12. Mean pain scores were ≤1.7 (scale of 0 to 10). Most ISRs with initial treatment were mild/moderate and resolved in ≤1 week, including tenderness (49.5%), bruising (42.7%), and swelling (41.7%). Thirty-four participants had treatment-emergent adverse events (TEAEs), of which 14 (10.3%) had treatment-related TEAEs, including bruising (3.8%) and swelling/edema (2.9%), which resolved in ≤2 weeks. Three participants had swelling/edema starting >30 days posttreatment; 2 resolved in ≤4 days, 1 by 45 days. No treatment-related serious AEs were reported.
conclusionsVYC-15L was safe and effective for the correction of moderate or severe infraorbital hollowing and lasted through 1 year. LEVEL OF EVIDENCE: 2:
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