A prospective multicenter clinical trial evaluating the efficacy and safety of a hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips and the perioral area |
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| Authors: | Agnès Ehlinger-David MD,Mihai Gorj MD,Frédéric Braccini MD,Federico Loreto MD,Anne Grand-Vincent MD,Philippe Garcia MD,Maryna Taieb MD,Laurent Benadiba MD,Isabelle Catoni MD,Elena Rumyantseva Mathey MD,Jean-Jacques Deutsch MD,Philippe Bahadoran MD,Thibaud Vincent MD,Michel David MD,Hugues Cartier MD,Karim Nadra PhD,Nicholas Moellhoff MD,Ferial Fanian MD, PhD |
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| Affiliation: | 1. Private clinic, Thionville, France;2. Private clinic, Paris, France;3. Private clinic, Nice, France;4. Private clinic, Neuilly-sur-Seine, France;5. Private clinique, Paris, France;6. Private clinic, Metz, France;7. Private clinic, Arras, France;8. Fillmed Laboratories, Paris, France;9. Division of Hand, Plastic and Aesthetic Surgery, University Hospital, LMU Munich, Munich, Germany |
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| Abstract: | Background Age-related changes of facial soft tissue cause clinical signs of facial aging such as lip atrophy, marionette lines, and an accentuated nasolabial fold. These changes can be modified using dermal fillers. Aims To evaluate efficacy, longevity, and safety of a cross-linked hyaluronic acid-based filler with Tri-Hyal technology in the treatment of lips, nasolabial folds, and marionette lines. Materials and Methods This prospective, multi-center trial evaluated injections of three different areas (lips, nasolabial fold alone, or with marionette wrinkles) with a soft tissue filler containing 25 mg/ml cross-linked hyaluronic acid and 0.3% lidocaine. Primary endpoint was the aesthetic correction 3 weeks after one injection session without touch-up. Follow-up was 18 months. Assessments were performed using the Global Aesthetic Score (GAS), clinical scoring based on photographic scales, high-frequency ultrasound imaging, and the Global Aesthetic Improvement Scale (GAIS). Results In total, 100 subjects were injected. GAS improved significantly for all treatment indications at 3 weeks (p < 0.0001). Success rates were highest for nasolabial folds (98.4%), followed by marionette lines (94.4%) and lips (73.5%). After 18 months post-injection, success was observed in 91%, 88%, and 33% of subjects injected into nasolabial folds, marionette lines, and lips, respectively. GAIS scored highest for nasolabial folds (SGAIS: 71%; IGAIS: 40%), followed by marionette lines (SGAIS: 56%; IGAIS: 33%) and lips (SGAIS: 30%; IGAIS: 22%) at 18 months follow-up. Conclusions The filler demonstrated high efficacy and safety in all indications. Regional differences in longevity were evident. Thus, the necessity of regional retreatments should be discussed with patients before injection. |
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| Keywords: | dermal filler facial aging hyaluronic acid lips volume perioral rejuvenation |
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