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 | Enrolling By Invitation

• 1 other identifier: Ellansé-S
• Study Type: observational
• Target: 374
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• AE/SAE

  1 month,6 months,1 year, 2 years,3years,4years,5years

• Improvement of WSRS scores

  1 month,6 months,1 year, 2 years

• GAIS scores after injection treatment

  1 month,6 months,1 year, 2 years

Interventions

Ellansé-S DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Obvious acne scar, pigmentation, active infection, inflammation, tumor, precancerous lesion or unhealed wound in the intended injection area;
• 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;
• 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;
• Patients who have received temporary fillers (hyaluronic acid, collagen, etc.) injection treatment in nasolabial groove in the past 12 months;
• Patients who have received botox injection treatment in nasolabial sulci in the past 6 months;
• The nasolabial groove has been treated with beauty plastic, focused ultrasound, chemical stripping, photoelectric (laser, photon, radio frequency) in the past 3 months;
• Use of hormones or immunosuppressants within the past 1 month;
• Subjects who have used anticoagulants in the last 2 weeks;
• Subjects with a history of crabfoot, hyperplastic scars or cicatricial constitution;
• Subjects with active sepsis;
• Subjects with coagulation dysfunction;
• Subjects with autoimmune diseases;
• Allergic to polycaprolactone or known product ingredients;
• Pregnant, pregnant and lactating subjects;
• Participated in other clinical trials in the past 30 days;

Sponsors & Collaborators

• AQTIS Medical B.V.: lead

Study Sites (1)

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: October 12, 2023
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)