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CC BY-NC-ND 4.0 · Facial Plast Surg 2023; 39(03): 300-306
DOI: 10.1055/a-1954-3986
Original Research

Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial

Hongyi Zhao
1   Department of Plastic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
,
Rongxin Ren
1   Department of Plastic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
,
Shiwei Bao
1   Department of Plastic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
,
Wenjiang Qian
1   Department of Plastic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
,
Xiaobing Ma
1   Department of Plastic Surgery, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
,
Ruiyan Wang
2   Department of Dermatology, Air Force Characteristic Medical Center, Beijing, People's Republic of China
,
Xiaoxin Li
2   Department of Dermatology, Air Force Characteristic Medical Center, Beijing, People's Republic of China
,
Rouyu Fang
3   Department of Dermatology, Peking Union Medical College Hospital, Beijing, People's Republic of China
,
Qiuning Sun
3   Department of Dermatology, Peking Union Medical College Hospital, Beijing, People's Republic of China
,
Yan Tian
2   Department of Dermatology, Air Force Characteristic Medical Center, Beijing, People's Republic of China
,
Chaonan Zhu
4   Huadong Medical Co. Ltd, Hangzhou, People's Republic of China
,
Jianling Shi
4   Huadong Medical Co. Ltd, Hangzhou, People's Republic of China
› Author Affiliations Funding None.
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Abstract

Nasolabial folds (NLFs) are the most pronounced sign of facial aging. This study explored the efficacy and safety of polycaprolactone gel in treating Chinese patients with moderate-to-severe NLFs. Patients with moderate-to-severe NLF who wished to be treated by dermal fillers were recruited from three centers between July 2017 and September 2019. The randomizing ratio was 1:1 in the polycaprolactone group (polycaprolactone injection) or control group (sodium hyaluronate gel injection). The primary endpoint was the effectiveness rate of Wrinkle Severity Rating Score (WSRS) scores at 12 months after injection. The full-analysis set (FAS) and safety sets had 80 patients in the polycaprolactone group and control group, respectively. In the FAS, the effectiveness rate at 12 months in the polycaprolactone group was 88.8% compared with 23.8% in controls (P < 0.001). The improvement in WSRS sustained during 12 months in the polycaprolactone group, while gradually vanished in the control group since 3 months after surgery. The global aesthetic improvement scale (GAIS) by investigator assessments was improved, much improved, or very much improved in all patients during follow-up, while the proportion of patients with a “no change” assessment gradually increased during follow-up after 6 months in the control group. The rates of injection-related adverse event (AE) and serve injection-related AE were 8.8 versus 11.3% and 0 versus 1.3% in the polycaprolactone group and control groups, respectively. Polycaprolactone gel injection is effective and safe to treat moderate-to-severe NLFs in Chinese patients.

Keywords

nasolabial fold - aesthetic - dermal filler - facial wrinkles - randomized controlled trial

Author Contributions

H.Z., Q.S., and Y.T. had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. H.Z. was involved in the study concepts and design. All authors (H.Z., R.R., S.B., W.Q., X.M, R.W., X.L., R.F., Q.S., and Y.T.) involved in the acquisition, analysis, and interpretation of data. C.Z. involved in data collection, J. S. and H. Z. involved in the draft of the manuscript.




Publication History

Accepted Manuscript online:
03 October 2022

Article published online:
27 December 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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