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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05935449
Study type Interventional
Source Maxigen Biotech Inc.
Contact
Status Completed
Phase N/A
Start date August 4, 2020
Completion date June 24, 2021

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