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

NCT05935449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-05-09

No results posted yet for this study

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.

Conditions

  • Dermal Fillers
  • Lidocaine
  • Hyaluronic Acid

Interventions

DEVICE

Formaderm Lidocaine

Dermal filler injection to facial areas

DEVICE

Formaderm Dermal Filler Injection

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
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2020-11-26
Completion
2021-06-24

Countries

  • Taiwan

Study Locations

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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 NCT05935449 on ClinicalTrials.gov