FACILLE modified sodium hyaluronate gel was designed to be used for nasolabial fold (NLF) correction. However, no study has investigated the long-term safety and effectiveness of FACILLE. Thus, a retrospective study o...FACILLE modified sodium hyaluronate gel was designed to be used for nasolabial fold (NLF) correction. However, no study has investigated the long-term safety and effectiveness of FACILLE. Thus, a retrospective study of 14 aesthetic clinics in China was conducted. This was the first large-scale, postmarketing study on FACILLE to evaluate the occurrence of adverse events (AEs) and provide essential information on the satisfaction of patients with FACILLE injections. This study recruited participants aged >18 years. FACILLE was injected into the NLFs on both sides of each participant’s face. The primary endpoint for safety was systemic or severe AEs at an injection site. Effectiveness was assessed on the basis of the participants’ subjective perceptions and satisfaction levels. Safety and effectiveness data were collected on the day of injection and at 2 weeks and 1, 3, 6, 9, 12, 18, 24, 30 and 36 months postinjection. In total, 1552 participants were enrolled (mean age, 29.1 years), and most of them (96.5%) were women. The mean injection volume was 1.39 ± 0.658 mL, and the average number of injections was 2.4 ± 1.68. AEs were reported by 205 participants (13.2%). All AEs occurred at local injection sites. No systemic or severe AEs were observed. Local pain was the most frequently reported AE regardless of the number of injections or the injection volume. Only eight AE cases were correlated with FACILLE administration, with two cases involving local allergic reactions. The participants self-reported that they perceived the procedure to have an effectiveness of ≥90% within 6 months postinjection although this percentage decreased substantially after 9 months. Their satisfaction level was >90% within 1 month postinjection but decreased gradually after 3 months. Our results indicate that the long-term safety of FACILLE injection is adequate. The high self-reported perceived effectiveness and satisfaction levels indicate the considerable potential of FACILLE injections for correcting NLFs.展开更多
BACKGROUND Nasolabial fold(NLF)depression can affect the facial appearance of patients to some extent and increase their psychological burdens.In recent years,autologous fat grafting(AFG)combined with botulinum toxin ...BACKGROUND Nasolabial fold(NLF)depression can affect the facial appearance of patients to some extent and increase their psychological burdens.In recent years,autologous fat grafting(AFG)combined with botulinum toxin A(BTX-A)injection(AFG+BTX-A injection)has been gradually applied in the treatment of patients with NLF depression.Although studies have been conducted on the efficacy and safety of AFG+BTX-A injection in treating NLF depression,the experimental design,observational indicators,and sample enrollment criteria vary remarkably,making it difficult to draw convincing and consistent conclusions.Thus,further relevant research is warranted.AIM To assess the esthetic improvement,efficacy,and safety of AFG+BTX-A injections in patients with NLF depression.METHODS This study included 60 patients with NLF depression who were treated in our hospital from February 2019 to April 2021.These patients were categorized into control(n=30)and observation(n=30)groups.The observation group received AFG+BTX-A injection,whereas the control group underwent AFG only.All patients were evaluated using the wrinkle severity rating scale(WSRS)and global aesthetic improvement scale.The compactness of facial contours,skin evaluation indexes,adverse reactions,and satisfaction of the two groups were evaluated 3 months postoperatively.RESULTS The WSRS scores of the observation group at 1,3,and 6 months postoperatively were lower than those of the control group(P<0.05).Three months postoperatively,facial fine lines and pores showed obvious improvement and the skin index score was higher in the observation group than in the control group(P<0.05).The compactness of facial contours was better in the observation group than in the control group(P<0.05).In addition,no remarkable differences were noted in the incidence of postoperative adverse reactions such as facial stiffness,facial asymmetry,facial bruising,and facial concavity inequality(P>0.05).CONCLUSION AFG+BTX-A injection is a highly safe,cost-effective,effective,and long-lasting treatment for NLF depression with high esthetic value,which should be promoted in the future.展开更多
文摘FACILLE modified sodium hyaluronate gel was designed to be used for nasolabial fold (NLF) correction. However, no study has investigated the long-term safety and effectiveness of FACILLE. Thus, a retrospective study of 14 aesthetic clinics in China was conducted. This was the first large-scale, postmarketing study on FACILLE to evaluate the occurrence of adverse events (AEs) and provide essential information on the satisfaction of patients with FACILLE injections. This study recruited participants aged >18 years. FACILLE was injected into the NLFs on both sides of each participant’s face. The primary endpoint for safety was systemic or severe AEs at an injection site. Effectiveness was assessed on the basis of the participants’ subjective perceptions and satisfaction levels. Safety and effectiveness data were collected on the day of injection and at 2 weeks and 1, 3, 6, 9, 12, 18, 24, 30 and 36 months postinjection. In total, 1552 participants were enrolled (mean age, 29.1 years), and most of them (96.5%) were women. The mean injection volume was 1.39 ± 0.658 mL, and the average number of injections was 2.4 ± 1.68. AEs were reported by 205 participants (13.2%). All AEs occurred at local injection sites. No systemic or severe AEs were observed. Local pain was the most frequently reported AE regardless of the number of injections or the injection volume. Only eight AE cases were correlated with FACILLE administration, with two cases involving local allergic reactions. The participants self-reported that they perceived the procedure to have an effectiveness of ≥90% within 6 months postinjection although this percentage decreased substantially after 9 months. Their satisfaction level was >90% within 1 month postinjection but decreased gradually after 3 months. Our results indicate that the long-term safety of FACILLE injection is adequate. The high self-reported perceived effectiveness and satisfaction levels indicate the considerable potential of FACILLE injections for correcting NLFs.
基金Supported by Medical and Health Science and Technology Project of Hangzhou,No.B20230855Hangzhou Science and Technology Plan Development Project,No.20210133X01.
文摘BACKGROUND Nasolabial fold(NLF)depression can affect the facial appearance of patients to some extent and increase their psychological burdens.In recent years,autologous fat grafting(AFG)combined with botulinum toxin A(BTX-A)injection(AFG+BTX-A injection)has been gradually applied in the treatment of patients with NLF depression.Although studies have been conducted on the efficacy and safety of AFG+BTX-A injection in treating NLF depression,the experimental design,observational indicators,and sample enrollment criteria vary remarkably,making it difficult to draw convincing and consistent conclusions.Thus,further relevant research is warranted.AIM To assess the esthetic improvement,efficacy,and safety of AFG+BTX-A injections in patients with NLF depression.METHODS This study included 60 patients with NLF depression who were treated in our hospital from February 2019 to April 2021.These patients were categorized into control(n=30)and observation(n=30)groups.The observation group received AFG+BTX-A injection,whereas the control group underwent AFG only.All patients were evaluated using the wrinkle severity rating scale(WSRS)and global aesthetic improvement scale.The compactness of facial contours,skin evaluation indexes,adverse reactions,and satisfaction of the two groups were evaluated 3 months postoperatively.RESULTS The WSRS scores of the observation group at 1,3,and 6 months postoperatively were lower than those of the control group(P<0.05).Three months postoperatively,facial fine lines and pores showed obvious improvement and the skin index score was higher in the observation group than in the control group(P<0.05).The compactness of facial contours was better in the observation group than in the control group(P<0.05).In addition,no remarkable differences were noted in the incidence of postoperative adverse reactions such as facial stiffness,facial asymmetry,facial bruising,and facial concavity inequality(P>0.05).CONCLUSION AFG+BTX-A injection is a highly safe,cost-effective,effective,and long-lasting treatment for NLF depression with high esthetic value,which should be promoted in the future.