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Enrolling by Invitation

NCT Number: 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

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

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Second People's Hospital

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Ellansé-S

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. AE/SAE

    Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years

    The incidence of AE/SAE will be collected for all visits.

  2. Improvement of WSRS scores

    Time frame: 1 month,6 months,1 year, 2 years

    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.

  3. GAIS scores after injection treatment

    Time frame: 1 month,6 months,1 year, 2 years

    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

Sponsors and collaborators

Lead sponsor

AQTIS Medical B.V.

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2029
First posted
Feb 6, 2024
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.