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The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT05935449•Maxigen Biotech Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects are aged 20-65 years old of both sexes.
•Subjects who have bilateral nasolabial folds with 3-4 points of WSRS baseline measurement.
•Subjects who are willing to undergo the dermal filling therapy.
•The facial skin is healthy, without any disease that possibly interferes with skin aging status assessment, i.e., facial nerve paralysis
•The subject is willing to avoid undergoing other cosmetic treatment and surgery for the entire duration of investigation.
•The subject is willing to adhere to the protocol and sign the Informed Consent before the investigation.

Exclusion Criteria

•Women subjects who are pregnant, breastfeeding, planning to become pregnant, and not willing to take contraception during the trial period.
•Subjects with history of allergies to hyaluronic acid.
•Subjects with history of allergies to lidocaine or amide-type local anesthetics.
•Those who are suffering from immunity related disorder.
•Those who are suffering from a mental disease.
•Those who are suffering from alcohol use disorder.
•Those who have severe heart, kidney, liver or respiratory system disorder.
•Those who have localized infection, severe skin disease, inflammation, tumor or other related disease in the nasolabial fold area.
•Those with a scar-prone constitution, prone to scar formation, hypertrophic scars or keloids.
•Those with coagulation disorder
+8 more criteria

Locations (2)

National Taiwan University Hospital

Taipei, Taiwan (r.o.c.), Taiwan

Tri-Service General Hospital

Taoyuan, Taiwan (r.o.c.), Taiwan

Key Dates

Start Date

August 4, 2020

Primary Completion Date

November 26, 2020

Completion Date

June 24, 2021

Last Updated

May 9, 2025

Enrollment

ACTUAL participants

Conditions

Dermal FillersLidocaineHyaluronic Acid

Interventions

Formaderm Lidocaine

DEVICE

Formaderm Dermal Filler Injection

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Intraoperative Infusion of Either Lidocaine or Dexmedetomidine on Regional Cerebral Oxygen Saturation and Postoperative Delirium in Elderly Patients Undergoing Abdominal Surgeries

Effect of Oral Melatonin Versus Intraoperative Lidocaine Infusion on Incidence of Postoperative Delirium in Elderly Patients Undergoing Total Hip Arthroplasty

Oral Supplementation Compared With Hyaluronic Acid Infiltration in Rotator Cuff Tendinopathies

Palatal Mucosa Wound Healing Following Antimicrobial Gel Application

Lidocaine-based Versus Opioid-based Induction of Anesthesia in Emergency Laparotomy

Workflow Optimization During Pulse Field Ablation for Atrial Fibrillation