Real-world patient satisfaction with hyaluronic acid filler HYC-24/HYC-24+ for the treatment of moderate to severe nasolabial folds in China
10.3760/cma.j.cn114453-20230315-00051
- VernacularTitle:透明质酸填充剂HYC-24/HYC-24＋治疗中国中、重度鼻唇沟皱褶患者满意度的真实世界研究
- Author:
Ling CAO
1
;
Weimin SONG
;
Shiliang XU
;
Zhifu SUI
;
Maglambayan JOY
;
Patel VAISHALI
Author Information
1. 北京丽都医疗美容医院整形外科，北京 100101
- Keywords:
Nasolabial fold;
Hyaluronic acid;
Patient satisfaction;
Asians;
Plastic surgery
- From:
Chinese Journal of Plastic Surgery
2024;40(4):436-443
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To assess the real-world patient satisfaction with the outcomes in Chinese patients who received HYC-24/HYC-24+ for the treatment of moderate to severe nasolabial folds (NLF).Methods:This study was a prospective, observational, multicenter, real-world cohort study in which patients accepted treatment with HYC-24/HYC-24+ in China during a period from August 2018 to August 2020 at Beijing Lidu Medical Beauty Hospital, Hangzhou Yanshu Yuerong Medical Aesthetic Clinic, and Guangzhou Yuexiu Plastic Surgery Hospital and were followed up for up to 1 year. Patients were adults aged 18 to 65 years with moderate to severe NLF who had not received cosmetic treatment for NLF within 6 months prior to study enrollment. Post-treatment study visits were conducted at Months 1, 6, 9, and 12, but only Months 6 and 9 were required visits. The primary patient-reported outcomes endpoints included the FACE-Q satisfaction with outcome total score (a score from 0 to 100: a higher score indicates better outcomes and higher patient satisfaction), FACE-Q appraisal of lines - NLFs total questionnaire score mean change from baseline (a score from 0 to 100: a higher score indicates the patient was less troubled by NLF in the past week), and proportion of patients who reported that they looked younger than the actual age on the FACE-Q patient perceived age visual analog scale (VAS). Investigator-assessed endpoints included the proportion of patients with a global aesthetic improvement scale (GAIS) score of ≥ 1 point and the proportion of patients with an improvement in NLF severity of ≥ 1 point using the nasolabial fold severity scale (NLFSS). Statistical analyses were performed with SAS software, version 9.4. Measurement data were expressed as Mean±SD, and count data were expressed using cases(%). For both measurement and count data, P values were calculated on the difference between score values at different time points versus baseline using the Wilcoxon signed rank test. Results:A total of 52 subjects were enrolled and treated. Among these subjects, 7 were not included in the 6-month effectiveness analysis data set because the visit time exceeded the visit assessment window, and only 9 patients completed the 12-month visit. All patients were Chinese women, aged 26 to 62 years old, with a mean age of 40.7 years. The FACE-Q satisfaction with outcome total score was (68.76 ± 21.03) points (38-100) at Month 6, and (65.44±18.24) points (24-100) at Month 9, indicating high patient satisfaction with the treatment. The FACE-Q appraisal of lines-NLFs total score was (42.4±15.1) points (10-69) at baseline, (76.9±20.6) points (36-100) at Month 6, and (74.2±16.7) points (36-100) at Month 9, both significantly higher than the baseline scores (both P<0.01). The mean change from baseline in the FACE-Q appraisal of lines-NLFs total scores at Month 6 and Month 9 were 34.9 and 31.8 points, respectively, indicating the disturbance caused by NLF was relatively mild after treatment. The proportion of patients who believed they looked younger than their actual age on the FACE-Q patient perceived age VAS increased from 28.9% (15/52) at baseline to 77.8% (35/45) at Month 6, and 73.1% (38/52 ) at Month 9. The differences were all statistically significant compared to baseline ( P <0.01). At each post-baseline visit, all patients had ≥ 1-point improvement on the GAIS scale, indicating an improvement in patient NLF appearance in the investigators’ opinion. In terms of the NLFSS assessment, 97.8% (44/45) and 82.7% (43/52) of patients achieved a ≥ 1-point improvement on the NLFSS at Months 6 and 9, respectively. No adverse events were reported during the study. Conclusion:In a real-world setting, after the administration of HYC-24/HYC-24+ to Chinese patients, the patients were satisfied with the outcomes based on validated questionnaires. The patients also reported looking younger than their actual age and being less disturbed by NLF. Clinician-reported outcomes were consistent with patient-reported outcomes, indicating improvement in NLF.
