Clinical trial NCT06243315: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face
Lead sponsor: AQTIS Medical B.V.
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


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;

Primary outcomes:
measure: MAEs
timeFrame: 1 month,6 months,1 year, 2 years,3years,4years,5years
Secondary outcomes:
measure: AE/SAE
timeFrame: 1 month,6 months,1 year, 2 years,3years,4years,5years
measure: Improvement of WSRS scores
timeFrame: 1 month,6 months,1 year, 2 years
measure: GAIS scores after injection treatment
timeFrame: 1 month,6 months,1 year, 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Second People's Hospital
state: Guangdong
Study officials:
References: