Trial reportAesthetic surgery journal2024
Lip Augmentation With Saypha LIPS Lidocaine: A Postmarket, Prospective, Open-Label, Randomized Clinical Study To Evaluate Its Efficacy and Short- and Long-term Safety.
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 8 papers, 1 of them a synthesis that pooled it.
What it found
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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
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Adverse Events in Nonsurgical Facial Aesthetic Procedures: A Systematic Review and Meta-Analysis.Oral diseases · 2026Pooled it
- The Safety Profile of a Portfolio of Hyaluronic Acid-Based Soft Tissue Fillers Manufactured Using MACRO Technology: A Systematic Review of Clinical Evidence.Life (Basel, Switzerland) · 2026Review
- Hyaluronic Acid Injection Techniques for Lip Augmentation-Comparison of Linear, Retrograde, and Microdeposit Approaches: A Systematic Review.Aesthetic surgery journal. Open forum · 2026Review
- The Lip Complexity Classification (LCC): A Proposed Framework Integrating Anatomical Assessment with Therapeutic Decision-Making in Lip Augmentation.Clinical, cosmetic and investigational dermatology · 2026Article
- Subject-Reported Satisfaction After Cell-Enriched Lipotransfer (CELT) for Lip Augmentation.Aesthetic plastic surgery · 2025Article
- A Scientific Framework for Comparing Hyaluronic Acid Filler Crosslinking Technologies.Gels (Basel, Switzerland) · 2025Article
- Combination of Hyaluronic Acid and Polynucleotides Injection for the Treatment of Cheilitis Simplex.Clinical, cosmetic and investigational dermatology · 2025Article
- Safety and Efficacy of a New Hyaluronic Acid Filler for Lip Augmentation: A Prospective, Multicenter, Randomized, Controlled Study.Aesthetic surgery journal. Open forum · 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
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundVersatility, biocompatibility, and reversibility make hyaluronic acid fillers the backbone of minimally invasive lip augmentation procedures.
objectivesThe aim of this study was to assess the effectiveness and short- and long-term safety of Saypha LIPS Lidocaine (Croma Pharma, Leobendorf, Austria) for lip augmentation to correct moderate to severe lip volume deficiency (grade 1-3 lip fullness score [LFS]).
methodsIn this postmarket, prospective, open-label, multicenter, randomized clinical study, 114 patients were initially treated (with optional touch-up treatment at Week 3). Retrograde and bolus techniques were employed with defined needles or cannula. The primary effectiveness endpoint was the proportion of patients with lip volume improvement of LFS ≥ 1 grade vs baseline at Week 6 (ie, responders); with follow-up (FU) for secondary effectiveness at Months 6, 12, and 18. Evaluation scores included the LFS, Global Aesthetic Improvement Scale (investigator and patient), patient satisfaction questionnaire FACE-Q, and a numerical pain rating scale.
resultsAt Week 6, >90% of the patients were responders (lower-lip: 95% CI, 92.24-99.43, P = .0071; upper-lip: 95% CI, 90.95-99.00, P = .0234), with post hoc analyses showing the outcome was influenced by the initial volume deficiency and total volume injected, but not by touch-up treatment. At Month 6, 90% of the patients were responders; at Month 12, 70%; and at Month 18, >40% still had a visible effect. Adverse events were mostly procedural, mild, and temporary. Pain perception was significantly reduced 15 minutes after the procedure. Aesthetic improvement and patient satisfaction were rated as high at all time points.
conclusionsSaypha LIPS Lidocaine for lip augmentation showed long-term aesthetic improvement and safety. LEVEL OF EVIDENCE: 2:
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