Trial reportAesthetic plastic surgery2023
Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial.
Trial report in Aesthetic plastic surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05215054 (Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment), which is not on this map. Cited by 13 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.
Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment
Who cites it
13 citing papers in PubMed, 25 citations in OpenAlex.
- Safety and Efficacy of Micronized Acellular Dermal Matrix Injection for Correction of Moderate to Severe Nasolabial Folds: A Double-Blind, Multicenter, Randomized Controlled, Non-inferior Clinical Trial.Aesthetic plastic surgery · 2026Trial
- Efficacy and Safety of Poly-l-Lactic Acid for Correction of Midfacial Volume Loss and Contour Defects: A Prospective, Multicenter, Randomized, Parallel-Controlled, Evaluator-Blinded, Superiority Trial.Journal of cosmetic dermatology · 2025Trial
- Regenerative Functional Microspheres for Aesthetic Medicine: Mechanism, Materials, Fabrication, and Clinical Applications.Advanced healthcare materials · 2026Review
- Efficacy and Outcomes of Pedicled Upper Orbital Fat Fascia Flap Transposition Using 3D Facial Scanning: A Retrospective Study.Aesthetic plastic surgery · 2026Article
- A Hybrid Gel of Hyaluronic Acid and Poly-L-Lactic Acid for Nasolabial Folds by Ligament-targeted Injection.Plastic and reconstructive surgery. Global open · 2026Article
- Clinical Outcomes of an Innovative Poly-L-Lactic Acid (LASYNPRO) in Facial Rejuvenation: Prospective, Multicenter Spanish Study.Journal of cosmetic dermatology · 2026Article
- Preparation of Uniform PEG-PLLA Microspheres via Membrane Emulsification for Soft Tissue Filling Applications.Journal of functional biomaterials · 2026Article
- Comprehensive Systematic Review of Poly-L-Lactic Acid in Facial Clinical Application.Aesthetic plastic surgery · 2025Article
- Comparing the Safety and Effectiveness of PCL and PLLA Injections for Nasolabial Fold Correction.Journal of cosmetic dermatology · 2025Article
- Advances in Poly-l-lactic Acid Injections for Facial and Neck Rejuvenation.Plastic and reconstructive surgery. Global open · 2025Article
- Letter to the Editor on: "Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial".Aesthetic plastic surgery · 2025Article
- Review
- Poly-lactic Acid Dermal Filler Enriched With InCubeIn vivo (Athens, Greece)Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPoly-L-lactic acid (PLLA) fillers have shown excellent results as soft tissue fillers for progressive midface volume enhancement, with long-lasting results and high patient satisfaction.
objectiveHerein, we investigated the safety and effectiveness of a new PLLA filler (Gana V) in comparison with those of the widely used Sculptra.
methodsThis double-blind, non-inferiority, randomized, split-face controlled trial was performed in France to evaluate the safety and effectiveness of injectable Gana V compared with those of Sculptra for correction of nasolabial fold (NLF) depression. The primary outcome was improvement in NLFs, as determined using the Wrinkle Severity Rating Scale (WSRS). This trial is an interim report of the results at 6 months. The trial was registered at ClinicalTrials. gov, number NCT05215054.
resultsFifty-five participants with moderate-to-severe NLFs (mean age 53.8 [standard deviation 8.7] years; 48 [87.3%]) female) were enrolled. After 6 months, Gana V showed improved WSRS score (mean difference - 0.25; 95% confidence interval [CI] - 0.49 to - 0.01) in intention-to-treat analysis, while Sculptra did not (mean difference - 0.20; 95% CI - 0.42 to 0.03). Furthermore, Gana V showed an acceptable 6-month effectiveness compared with Sculptra, within our defined non-inferiority margin (p
conclusionsGana V is non-inferior to Sculptra with respect to the correction of NLFs and has higher investigator satisfaction. Further research is required to ensure long-term safety. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .
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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 Socratic graph.