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

NCT ID: NCT06243315

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 374 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2029-09-30

Brief Summary

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

Conditions

Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ellansé-S

It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AQTIS Medical B.V.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

Ellansé-S

Identifier Type: -

Identifier Source: org_study_id