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

AQTIS Medical B.V.

Status: Invitation-only

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

Treatments: Device: Ellansé-S

Study type: Observational

Funder types: Other

Identifiers

NCT06243315

Ellansé-S

Details and patient eligibility

About

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

Enrollment: 374 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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;