MedTrace Logo

Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler

NCT05935501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2023-07-07

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles.

The main questions it aims to answer are:

* The differences of Wrinkle Severity Rating Scale (WSRS) after the injection.
* The treatment improvement assessed by Global Aesthetic Improvement Scale (GAIS).
* Safety Indicators of which incidences on the day of the injection or after the injection.

Participants will be blinded and randomized into either experiment group or control group, and re-visited on 1, 3, 6, 9 and 12 month after injection.

Researchers will compare if the test product is non-inferiority to Restylane.

Conditions

  • Hyaluronic Acid
  • Dermal Fillers

Interventions

DEVICE

Formaderm Young

Dermal filler injection to facial areas.

DEVICE

Restylane

Dermal filler injection to facial areas.

Sponsors & Collaborators

  • Maxigen Biotech Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-27
Primary Completion
2021-10-20
Completion
2023-04-06

Countries

  • China

Study Locations

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 NCT05935501 on ClinicalTrials.gov