The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
Abstract
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.
Conditions: Dermal Fillers, Lidocaine, Hyaluronic Acid.
Primary outcome: Immediately Pain Score Using Visual Analog Pain Scale(VAS).
Enrollment: 42 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 42 participants or records.
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