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To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds

NCT07343141 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2026-01-15

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of a poly-L-lactic acid (PLLA) dermal implant for the correction of nasolabial folds. The study also aims to determine whether the investigational product (FUYANMEI Poly-L-Lactic Acid) is non-inferior to the control product (Sculptra).

The main questions it aims to answer are:

* Is the effectiveness rate based on the Wrinkle Severity Rating Scale (WSRS) at 6 months after injection for the investigational group non-inferior to that of the control group?
* How does the investigational product perform in terms of global aesthetic improvement as assessed by blinded evaluators and by subjects?
* What is the safety profile of the investigational product, including the incidence, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and device deficiencies (DDs)?

Researchers will compare the investigational PLLA implant to an approved PLLA implant using a prospective, randomized, evaluator- and subject-blinded, single-center, split-face controlled study design. Approximately 121 eligible participants will be enrolled.

Participants will:

* Receive treatment with the investigational product and the control product according to the split-face design
* Be followed for 24 months after injection
* Return to the clinic at 1, 3, 6, 12, 18, and 24 months post-injection for follow-up visits
* Undergo blinded evaluator assessments of WSRS and Global Aesthetic Improvement Scale (GAIS)
* Complete subject self-assessments of GAIS and treatment satisfaction
* Be monitored throughout the study for adverse events, serious adverse events, and medical device deficiencies

Conditions

  • Nasolabial Fold Correction

Interventions

DEVICE

FUYANMEI Poly-L-Lactic Acid

Poly-L-Lactic Acid

DEVICE

Sculptra®

Poly-L-Lactic Acid

Sponsors & Collaborators

  • SciVision Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-02-28
Completion
2028-08-31

Countries

  • Taiwan

Study Locations

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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 NCT07343141 on ClinicalTrials.gov