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Clinical Trials in China / NCT06243315
Enrolling by invitation Observational

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

NCT06243315 · tracked via the Priya Life Science China tracker
Sponsor
AQTIS Medical B.V.
Phase
Observational
Started
2023-10-12
Last updated
2025-04-29

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Ellansé-S

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

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
Accepted
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Guangdong Second People's Hospital Guangzhou Guangdong

More AQTIS Medical B.V. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06243315 on ClinicalTrials.gov ↗ ← All trials in China