This research is intended to evaluate the long-term safety of Ellansé-S PCL dermal filler for the correction of moderate-to-severe NLFs. 374 subjects. This clinical trial is designed as a prospective, multicenter, post-marketing clinical follow-up trial to evaluate the long-term safety of the investigational product, dermal filler made of PCL microspheres, for the correction of moderate-to-severe NLFs
Study Type
OBSERVATIONAL
Enrollment
374
It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs
Guangdong Second People's Hospital
Guangzhou, Guangdong, China
MAEs
The incidence of MAEs associated with the investigational product will be collected for all visits
Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years
AE/SAE
The incidence of AE/SAE will be collected for all visits.
Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years
Improvement of WSRS scores
During screening visits and postoperative follow-up, investigators will use digital cameras to take standardized digital photos of the subjects on both sides. Based on the severity of the nasolabial folds on both sides of the subjects, the improvement of WSRS scores of the nasolabial folds at 1 month 1, 6 months, 1 year, and 2 years postoperative will be calculated compared to the baseline. Please refer to the appendix for the scoring criteria.
Time frame: 1 month,6 months,1 year, 2 years
GAIS scores after injection treatment
Scores on the General Aesthetic Improvement Scale (GAIS) will be collected on both sides of the face at postoperative visit points (1 month postoperative , 6 months postoperative, 1 year postoperative, and 2 years postoperative) based on images obtained from standardized postoperative photographs. Please refer to the appendix for the scoring criteria
Time frame: 1 month,6 months,1 year, 2 years
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