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Peer-reviewedCC BY 4.0Journal of Cosmetic Dermatology

Safety and Efficacy of Poly‐L‐Lactic Acid Filler (HYZ vs. Löviselle) Injection for Nasolabial Fold Correction: A Double‐Blind, Non‐Inferiority, Randomized, Controlled Trial

  • Zhanhong Li1
  • Jingfang Sun1,2
  • Lianbo Zhang3
  • Aili Cui4
  • Sha Huang5
  • Yaowu Dong6
  • Haibo Guo1,7
  • Yongmei Shi1
  • Xiaoyi Qiu1
  • Qiuting Huang1
  • Xiang Gao1
  • Yuan Yuan1
12 more authors
  • Yanqi Ye8
  • Xiao Wang9
  • Liang Chen10
  • Chongguo Liang11
  • Liwei Wu12
  • Junlong Guo13
  • Xiaojuan Zhang14
  • Wenting Chen15
  • Ping Yu16
  • Jing Lv17
  • Fengsheng Che1
  • Qiong Meng1,18,19
19 affiliations
  1. 1Sihuan Pharmaceutical Holdings Group Ltd. Beijing China
  2. 2Meiyan Space, Sihuan Pharmaceutical Holdings Group Ltd. Beijing China
  3. 3Department of Plastic Surgery China‐Japan Union Hospital of Jilin University Jilin China
  4. 4Department of Medical Cosmetology Yanbian University Hospital Jilin China
  5. 5Department of Plastic Surgery, Shulan (Hangzhou) Hospital, Shulan International Medical College Zhejiang Shuren University Hangzhou China
  6. 6Department of Otolaryngology Tonghua Central Hospital Tonghua China
  7. 7Beijing Aohe Pharmaceutical Research Institute Co., Ltd. Beijing China
  8. 8Department of Cosmetic Dermatology Beijing MYLIKE Medical Cosmetic Hospital Beijing China
  9. 9Department of Cosmetic Dermatology Shenzhen Xi'en Medical Cosmetic Clinic Shenzhen China
  10. 10Department of Cosmetic Dermatology Anhui Haobai Medical Cosmetic Clinic Hefei China
  11. 11Department of Cosmetic Dermatology Hainan Yishangmei Medical Cosmetic Clinic Haikou China
  12. 12Department of Cosmetic Dermatology Wenzhou Peace International Hospital Wenzhou China
  13. 13Department of Cosmetic Dermatology Qingdao Doctor Medical Cosmetic Hospital Qingdao China
  14. 14Department of Cosmetic Dermatology Qingdao LORD Medical Cosmetic Hospital Qingdao China
  15. 15Department of Cosmetic Dermatology Shenzhen MYLIKE Medical Cosmetic Hospital Shenzhen China
  16. 16Department of Cosmetic Dermatology Sichuan Huamei Zixin Plastic Surgery Hospital Chengdu China
  17. 17Department of Cosmetic Dermatology Chongqing Xinfu Medical Cosmetic Clinic Chongqing China
  18. 18Hunan University of Medicine Huaihua China
  19. 19School of Pharmaceutical Sciences Sun Yat‐Sen University Guangzhou China
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Abstract

Background: Poly‐L‐lactic acid (PLLA) is an established soft‐tissue filler for correcting nasolabial folds (NLFs), offering durable results and high patient satisfaction. This study evaluated the efficacy and safety of a novel PLLA filler (HYZ) for this indication.

Methods: In this prospective, multicenter, randomized, double‐blind, non‐inferiority clinical trial, 176 subjects were randomly assigned to two groups, were randomized to receive three sessions of either HYZ (experimental group) or Löviselle (control group) injections at 3‐week intervals. Efficacy was assessed using the Global Aesthetic Improvement Scale (GAIS) and the Wrinkle Severity Rating Score (WSRS). Safety was evaluated based on adverse events (AEs).

Results: From baseline to Week 54, the HYZ group consistently showed higher WSRS response rates than the control group. At Week 54, the response rate was significantly higher in the HYZ group (54.02% vs. 36.36%, p < 0.05), meeting the predefined non‐inferiority margin (Δ = −10%). No significant between‐group differences were observed in GAIS response rates. The incidence of adverse events was comparable between the two groups.

Conclusion: The novel PLLA filler (HYZ) was non‐inferior to the established product Löviselle in both efficacy and safety for NLF correction. These findings provide new clinical evidence supporting the continued development and optimization of PLLA‐based fillers.

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Cite

BibTeXRIS
BibTeX
@article{li2026safety,
  title = {{Safety and Efficacy of Poly‐L‐Lactic Acid Filler (HYZ vs. Löviselle) Injection for Nasolabial Fold Correction: A Double‐Blind, Non‐Inferiority, Randomized, Controlled Trial}},
  author = {Zhanhong Li and Jingfang Sun and Lianbo Zhang and Aili Cui and Sha Huang and Yaowu Dong and Haibo Guo and Yongmei Shi and Xiaoyi Qiu and Qiuting Huang and Xiang Gao and Yuan Yuan and Yanqi Ye and Xiao Wang and Liang Chen and Chongguo Liang and Liwei Wu and Junlong Guo and Xiaojuan Zhang and Wenting Chen and Ping Yu and Jing Lv and Fengsheng Che and Qiong Meng},
  journal = {Journal of Cosmetic Dermatology},
  year = {2026},
  month = oct,
  doi = {10.1111/jocd.71260},
  url = {https://doi.org/10.1111/jocd.71260},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Safety and Efficacy of Poly‐L‐Lactic Acid Filler (HYZ vs. Löviselle) Injection for Nasolabial Fold Correction: A Double‐Blind, Non‐Inferiority, Randomized, Controlled Trial
AU  - Zhanhong Li
AU  - Jingfang Sun
AU  - Lianbo Zhang
AU  - Aili Cui
AU  - Sha Huang
AU  - Yaowu Dong
AU  - Haibo Guo
AU  - Yongmei Shi
AU  - Xiaoyi Qiu
AU  - Qiuting Huang
AU  - Xiang Gao
AU  - Yuan Yuan
AU  - Yanqi Ye
AU  - Xiao Wang
AU  - Liang Chen
AU  - Chongguo Liang
AU  - Liwei Wu
AU  - Junlong Guo
AU  - Xiaojuan Zhang
AU  - Wenting Chen
AU  - Ping Yu
AU  - Jing Lv
AU  - Fengsheng Che
AU  - Qiong Meng
PY  - 2026
DA  - 2026/10/25
JO  - Journal of Cosmetic Dermatology
DO  - 10.1111/jocd.71260
UR  - https://doi.org/10.1111/jocd.71260
AB  - Background: Poly‐L‐lactic acid (PLLA) is an established soft‐tissue filler for correcting nasolabial folds (NLFs), offering durable results and high patient satisfaction. This study evaluated the efficacy and safety of a novel PLLA filler (HYZ) for this indication.  Methods: In this prospective, multicenter, randomized, double‐blind, non‐inferiority clinical trial, 176 subjects were randomly assigned to two groups, were randomized to receive three sessions of either HYZ (experimental group) or Löviselle (control group) injections at 3‐week intervals. Efficacy was assessed using the Global Aesthetic Improvement Scale (GAIS) and the Wrinkle Severity Rating Score (WSRS). Safety was evaluated based on adverse events (AEs).  Results: From baseline to Week 54, the HYZ group consistently showed higher WSRS response rates than the control group. At Week 54, the response rate was significantly higher in the HYZ group (54.02% vs. 36.36%, p < 0.05), meeting the predefined non‐inferiority margin (Δ = −10%). No significant between‐group differences were observed in GAIS response rates. The incidence of adverse events was comparable between the two groups.  Conclusion: The novel PLLA filler (HYZ) was non‐inferior to the established product Löviselle in both efficacy and safety for NLF correction. These findings provide new clinical evidence supporting the continued development and optimization of PLLA‐based fillers.
SN  - 1473-2130
SN  - 1473-2165
ER  -