A Prospective, Multicenter, Post-marketing Clinical Follo... | NCT06243315

Studies
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

Sponsor

AQTIS Medical B.V.

Status

Enrolling by invitation

Last Update Posted

Apr 29, 2025Actual

Enrollment

374Estimated

Phase

Not provided

Conditions

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

Interventions

Ellansé-S

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 12, 2023Actual

Primary Completion Date

Sep 2029Estimated

Completion Date

Sep 2029Estimated

First Submitted Date

Jan 29, 2024

First Submission Date that Met QC Criteria

Feb 5, 2024

First Posted Date

Feb 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 25, 2025

Last Update Posted Date

Apr 29, 2025Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

374Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ellansé-S	Device	It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
AE/SAE	The incidence of AE/SAE will be collected for all visits.	1 month,6 months,1 year, 2 years,3years,4years,5years
Improvement of WSRS scores	During screening visits and postoperative follow-up, investigators will use digital cameras to take standardized digital photos of the subjects on both sides. Based on the severity of the nasolabial folds on both sides of the subjects, the improvement of WSRS scores of the nasolabial folds at 1 month 1, 6 months, 1 year, and 2 years postoperative will be calculated compared to the baseline. Please refer to the appendix for the scoring criteria.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 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

Exclusion Criteria:

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;
Other situations determined by the researcher to be unsuitable for participation in this study;

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

This research will prospectively enroll and follow up all eligible subjects aged 18 years and older with moderate-to-severe NLFs.

Sampling Method

Non-Probability Sample