Trial reportAesthetic surgery journal2025
Long-term Safety and Effectiveness of Cold-Crosslinked Hyaluronic Acid Fillers: Multicenter, Randomized, Controlled, Double-Blind Study.
Trial report in Aesthetic surgery journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed.
- When Genes Meet Gels: Computational Immunogenetics of Dermal Fillers and Stratified Risk of Immune and Fibrotic Reactions across Compositions and Genotypes.Aesthetic plastic surgery · 2026Article
- Cosmetic Medicine and Aesthetic Surgery Journal: The Beautiful Bond Between Noninvasive Aesthetic Medicine and Plastic Surgery.Aesthetic surgery journal · 2026Article
- Statistical Superiority Without Clinical Relevance: A Critical Appraisal of Recent Hyaluronic Acid Filler Studies.Aesthetic surgery journal · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
backgroundEvolysse Form (EVLF) and Evolysse Smooth (EVLS) (Symatese, Chaponost, France) are new hyaluronic acid fillers created using an innovative cold-crosslinking process.
objectivesThe authors of this study aim to collect safety and effectiveness data on new cold-crosslinked fillers to support the US approval for the correction of moderate-to-severe dynamic facial wrinkles and folds.
methodsIn this randomized, controlled, split-face study, 140 patients with moderate-to-severe nasolabial folds (NLFs) received a cold-crosslinked filler in 1 NLF (EVLF = 70, EVLS = 70) and a traditionally crosslinked filler, Restylane-L (RESL), in the contralateral fold and were followed through 12 months with an optional retreatment at that time point and subsequent 3 months of safety follow-up.
resultsThe primary endpoint of mean Wrinkle Severity Rating Scale change from baseline to Month 6 as rated by the photographic review panel demonstrated noninferiority and statistical superiority for the cold-crosslinked fillers. Blinded evaluator Wrinkle Severity Rating Scale assessments showed a mean change from baseline that was statistically significantly better than RESL for EVLF at all visits through 12 months and for EVLS at 6 and 9 months. Most patients were responders on the Global Aesthetic Improvement Scale throughout the study, according to ratings by blinded evaluators, treating investigators, and patients. The FACE-Q appraisal of NLFs' overall mean score showed significant improvement from baseline (P < .0001) at all time points through Month 12 for all treatment groups. All treatments were well tolerated.
conclusionsThe new cold-crosslinked fillers were shown to be safe and effective for correction of NLFs, with results lasting for 1 year. LEVEL OF EVIDENCE: 1 (THERAPEUTIC):
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Registered trials
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.