NCT05935501

Clinical Trial of Cross-linked Hyaluronic Acid Dermal Filler

Safety and Efficacy of Formaderm Young Dermal Filler Injection for the Correction of Moderate-to-severe Facial Wrinkles.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Maxigen Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

A prospective, parallel, two-center, non-inferior, randomized, double-blind trial was conducted in this study. It was planned to recruit 157 subjects for each group, considering a 10% dropout rate that would lead to 320 subjects overall. Subjects eligible in the screening will be enrolled. Each patient will receive the same treatment, either Formaderm Young Dermal Filler Injection or Restylane, to correct both sides of the nasolabial fold through randomization. Clinical efficacy will be assessed by the blinded physician using the WSRS and GAIS, as well as by subjects using GAIS. The safety issue of Formaderm Young or Restylane will be identified and recorded during the course of the study.

Conditions

• Hyaluronic Acid
• Dermal Fillers

Interventions

Type	Name	Description
DEVICE	Formaderm Young	Dermal filler injection to facial areas.
DEVICE	Restylane	Dermal filler injection to facial areas.

Timeline

• Start date: 2018-08-27
• Primary completion: 2021-10-20
• Completion: 2023-04-06
• First posted: 2023-07-07
• Last updated: 2023-07-07

Locations

2 sites across 1 country: China