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Enrolling by invitation 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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ellansé-S.
Who it may be relevant to
Registry conditions: Moderate-to-severe Nasolabial Folds (3-4 Level of WSRS Scores) on Both Sides of the Face. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device Ellansé-S
    It is indicated for subcutaneous implantation to correct moderate-to-severe NLFs

Primary outcome measures

  • MAEs [Time frame: 1 month,6 months,1 year, 2 years,3years,4years,5years]
Secondary outcome measures (3)
  • 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]

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Guangdong Second People's Hospital — Guangzhou

Identifiers

NCT: NCT06243315 · Ellansé-S

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗