Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the FaceNCT06243315
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
An observational study of Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face, run by AQTIS Medical B.V. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face
- What is being tested?
- Ellansé-S
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 374 participants
- Where
- 1 siteChina
- Study dates
- 12 Oct 2023to Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This research will prospectively enroll and follow up all eligible subjects aged 18 years and older with moderate-to-severe NLFs.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Ellansé-S
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ellansé-SDevice
It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs
What is being measured
The primary outcome is the main question the study is designed to answer.
MAEs
The incidence of MAEs associated with the investigational product will be collected for all visits
Measured: 1 month,6 months,1 year, 2 years,3years,4years,5years
Secondary outcomes (3)
AE/SAE
The incidence of AE/SAE will be collected for all visits.
Measured: 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.
Measured: 1 month,6 months,1 year, 2 years
GAIS scores after injection treatment
Scores on the General Aesthetic Improvement Scale (GAIS) will be collected on both sides of the face at postoperative visit points (1 month postoperative , 6 months postoperative, 1 year postoperative, and 2 years postoperative) based on images obtained from standardized postoperative photographs. Please refer to the appendix for the scoring criteria
Measured: 1 month,6 months,1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start12 Oct 2023
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AQTIS Medical B.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06243315
- Sponsor's protocol ID
- Ellansé-S
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06243315
- Acronym / sponsor ID
- Ellansé-S
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- AQTIS Medical B.V.University, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This research will prospectively enroll and follow up all eligible subjects aged 18 years and older with moderate-to-severe NLFs.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ellansé-SIt is indicated for subcutaneous implantation to correct moderate-to-severe NLFs | Device | – |
Primary outcome
MAEs
Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years
The incidence of MAEs associated with the investigational product will be collected for all visits
3 secondary outcomes
AE/SAE
Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years
Improvement of WSRS scores
Time frame: 1 month,6 months,1 year, 2 years
GAIS scores after injection treatment
Time frame: 1 month,6 months,1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face, run by AQTIS Medical B.V. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MAEs (time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.