Characteristics and trends in clinical studies on aesthetic and plastic medical devices in China
10.3760/cma.j.cn114453-20220715-00220
- VernacularTitle:中国整形美容医疗器械注册临床研究的特征和发展趋势
- Author:
Yuhang CHE
1
;
Yilue ZHENG
;
Yongqian WANG
;
Haiyue JIANG
;
Kexin CHEN
;
Ning LI
;
Jiewei WU
;
Yan YAN
Author Information
1. 中国医学科学院北京协和医学院整形外科医院临床试验机构办公室，北京 100144
- Keywords:
Cosmetic techniques;
Surgery, plastic;
Medical device;
Non-invasive plastic surgery;
Minimally invasive plastic surgery;
Clinical study;
Trends in research
- From:
Chinese Journal of Plastic Surgery
2022;38(12):1390-1396
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To systematically describe the characteristics and trends of clinical studies on aesthetic and plastic devices from 2016 to 2020 in China.Methods:Clinical studies on aesthetic and plastic devices conducted in China from 2016 to 2020 were identified through ClinicalTrials.gov and the Chinese Clinical Trial Registry using predetermined search strings. Data on indications, medical device, sponsor type, and study design were collected and analyzed.Results:From 2016 to 2020, 118 registered clinical studies were identified and analyzed, among which 100 trials (84.7%) were initiated by medical institutions and the remaining were initiated by medical device enterprises. The number of studies increased from 12 to 42 from 2016 to 2020 with an average annual growth rate of 39.6%. For indication types, there are 90(76.3%) studies on skin defects, followed by 21(17.8%) on maxillofacial defects, 5(4.2%) on hair defects and 2(1.7%) on breast defects. The top four indications were scars, acne, nasolabial folds, and port-wine stains. For device types, photoelectric devices were involved in 73(61.9%) studies, followed by surgical devices [20(16.9%)] and injection devices [19(16.1%)]. Laser devices were the research focus among all photoelectric device categories. There were 11 clinical studies on scar treatment using laser treatment equipment, of which 6 trials applied parallel controlled study design, and the remaining trials applied self-controlled design. The sample size of these 11 trials ranged from 15 to 110.Conclusions:The number of registered clinical studies on aesthetic and plastic devices kept growing in the last few years. Skin related indications and photoelectric devices have become the hot spot in the field.
