A Prospective, Multicenter, Post-marketing Clinical Follow-up Research to Evaluate the Long-term Safety of Ellansé-S Dermal Filler Made of PCL Microspheres for the Correction of Moderate-to-severe Nasolabial Folds

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 Overview

• Status: Enrolling by invitation
• Conditions: Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face
• Intervention / Treatment: Device: Ellansé-S

• Study Type: Observational
• Enrollment (Estimated): 374

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Second People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This research will prospectively enroll and follow up all eligible subjects aged 18 years and older with moderate-to-severe NLFs.

Description

Inclusion Criteria:

1. 18 years old and above;
2. Subjects with moderate-to-severe nasolabial folds (3-4 level of WSRS scores) on both sides of the face
3. Intended to be treated with PCL microsphere filler;
4. Voluntarily participate in this test, cooperate with follow-up, and sign an informed consent form

Exclusion Criteria:

1. Obvious acne scar, pigmentation, active infection, inflammation, tumor, precancerous lesion or unhealed wound in the intended injection area;
2. Patients who have used permanent fillers (PMMA, hydrogel polymer, liquid silicone for injection, polyvinyl alcohol (PVA), bone cement, autologous fat, etc.) for nasolabial groove injection;
3. Patients who have received semi-permanent fillers (polycaprolactone, L-polylactic acid, hydroxyapatite, platelet-rich plasma, etc.) injection treatment in nasolabial sulch area in the past 24 months;
4. Patients who have received temporary fillers (hyaluronic acid, collagen, etc.) injection treatment in nasolabial groove in the past 12 months;
5. Patients who have received botox injection treatment in nasolabial sulci in the past 6 months;
6. The nasolabial groove has been treated with beauty plastic, focused ultrasound, chemical stripping, photoelectric (laser, photon, radio frequency) in the past 3 months;
7. Use of hormones or immunosuppressants within the past 1 month;
8. Subjects who have used anticoagulants in the last 2 weeks;
9. Subjects with a history of crabfoot, hyperplastic scars or cicatricial constitution;
10. Subjects with active sepsis;
11. Subjects with coagulation dysfunction;
12. Subjects with autoimmune diseases;
13. Allergic to polycaprolactone or known product ingredients;
14. Pregnant, pregnant and lactating subjects;
15. Participated in other clinical trials in the past 30 days;
16. Other situations determined by the researcher to be unsuitable for participation in this study;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAEs	The incidence of MAEs associated with the investigational product will be collected for all visits	1 month,6 months,1 year, 2 years,3years,4years,5years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE/SAE	The incidence of AE/SAE will be collected for all visits.	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.	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	1 month,6 months,1 year, 2 years

Collaborators and Investigators

• Sponsor: AQTIS Medical B.V.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Ellansé-S

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No