NCT05935449

The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Maxigen Biotech Inc. · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Lidocaine to the correction of nasolabial folds wrinkle and reduction of pain immediately after treatment. The main questions it aims to answer are: 1. The pain score assessed using Visual Analog Pain Scale(VAS) and Thermometer Pain Scale(TPS). 2. The facial wrinkle assessed using Wrinkle Severity Rating Scales(WSRS). 3. The treatment improvement assessed using Global Aesthetic Improvement Scale (GAIS). 4. Safety Indicators of which incidences on the day of the injection or after the injection. Participants will be self-controlled and randomized for same period, * received both trial product and control product at the same time. * re-visited on Day 14 and Day 30 after injection. The researchers will compare whether Formaderm Lidocaine is superior to Formaderm Dermal Filler Injection (without lidocaine) in terms of pain relief experienced by subjects during injection.

Detailed description

This is a two-center, randomized, self-controlled, double-blind trial. Each subject received the trial product and control product injections at the same time to assess the safety and efficacy of Formaderm Lidocaine, which is a hyaluronic acid dermal filler injection with lidocaine.

Conditions

• Dermal Fillers
• Lidocaine
• Hyaluronic Acid

Interventions

Type	Name	Description
DEVICE	Formaderm Lidocaine	Dermal filler injection to facial areas
DEVICE	Formaderm Dermal Filler Injection	Dermal filler injection to facial areas

Timeline

• Start date: 2020-08-04
• Primary completion: 2020-11-26
• Completion: 2021-06-24
• First posted: 2023-07-07
• Last updated: 2025-05-09

Locations

2 sites across 1 country: Taiwan