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

NCT ID: NCT05935449

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2021-06-24

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Formaderm Lidocaine

Formaderm Lidocaine was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c.

Group Type: EXPERIMENTAL

Formaderm Lidocaine

Intervention Type: DEVICE

Dermal filler injection to facial areas

Formaderm Dermal Filler Injection

Formaderm Dermal Filler Injection was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c.

Group Type: ACTIVE_COMPARATOR

Formaderm Dermal Filler Injection

Intervention Type: DEVICE

Dermal filler injection to facial areas

Interventions

Formaderm Lidocaine

Dermal filler injection to facial areas

Intervention Type: DEVICE

Formaderm Dermal Filler Injection

Dermal filler injection to facial areas

Intervention Type: DEVICE

Eligibility Criteria

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
• Patients undergoing anticoagulant treatment or taking non-steroidal anti-inflammatory drug(NSAID) within the past 1 week before screening.
• Those with permanent implants in the nasolabial fold area.
• Those who have undergone chemical peels treatment within the last 4 weeks before screening.
• Those who have undergone cosmetic treatment or surgery prior in the nasolabial fold area within the last 24 weeks before screening, such as botox injections, laser treatment of dermal lesions, or plastic surgery.
• Those who have undergone nasolabial fold augmentation treatment within the past 52 weeks before screening, such as autologous fat grafting, hyaluronic acid implants or collagen implants.
• Those who have joined other clinical trials within the past 12 weeks before screening (except for the clinical trials of questionnaire or sample collection)
• Those who are unable to comply with re-visit schedule.
• Those whose medication and medical conditions are deemed unfit for inclusion in the research based on the judgment of the researcher.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxigen Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

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

Tri-Service General Hospital

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

Countries

Taiwan

Other Identifiers

0176TC10

Identifier Type: -

Identifier Source: org_study_id