MedTrace Logo

A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds

NCT06961448 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-05-08

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender.

The main questions it aims to answer are:

* Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)?
* Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection.

Participants will:

* Receive either Lafullen or Restylane via injection in the nasolabial fold area.
* Optionally receive a touch-up injection at 4 weeks after the first treatment if needed.
* Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment.
* Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety.
* Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).

Conditions

  • Nasolabial Fold Correction

Interventions

DEVICE

Hyaluronate Gel for Injection

Apply a maximum of 1.5 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment.

DEVICE

Polycaprolactone microsphere filler

Apply a maximum of 1.0 mL per side of the nasolabial fold using the test device (Lafullen) or the control device, with an optional touch-up of up to 0.5 mL per side at 4 weeks based on investigator assessment.

Sponsors & Collaborators

  • Hangzhou Inshow Biotechnology Co.,Ltd.

    collaborator UNKNOWN

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-01
Completion
2026-11-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06961448 on ClinicalTrials.gov