Guangdong Second People's Hospital
Guangzhou, Guangdong, China
NCT Number: NCT06243315
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Guangzhou, Guangdong, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs
Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years
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
The incidence of AE/SAE will be collected for all visits.
Time frame: 1 month,6 months,1 year, 2 years
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
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
AQTIS Medical B.V.
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.