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

NCT05935449 | Completed

• 1 other identifier: 0176TC10
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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:

• 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

Outcome Measures

Primary Outcomes (1)

• Immediately Pain Score Using Visual Analog Pain Scale(VAS)

  Assess the pain score immediately after application of Formaderm Lidocaine and Formaderm Dermal Filler Injection(without Lidocaine) at nasolabial fold by utilizing subject reported visual analog pain scale (1 = no pain, 10 = excruciating pain).

  immediately after injection

Secondary Outcomes (6)

• Pain Score Using Visual Analog Pain Scale(VAS)

  15, 30, 45, 60 minutes after injection

• Pain Score Using Thermometer Pain Scale(TPS)

  immediately after injection

• Wrinkle Severity Rating Scales(WSRS) improvement ratio

  Baseline, Day 14, Day 30

• GAIS score assessed by physician

  Day 14, Day 30

• GAIS score assessed by subjects

  Day 14, Day 30

Study Arms (2)

Formaderm Lidocaine

EXPERIMENTAL

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

Device: Formaderm Lidocaine

Formaderm Dermal Filler Injection

ACTIVE COMPARATOR

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

Device: Formaderm Dermal Filler Injection

Interventions

Formaderm Lidocaine DEVICE

Dermal filler injection to facial areas

Formaderm Lidocaine

Formaderm Dermal Filler Injection DEVICE

Dermal filler injection to facial areas

Formaderm Dermal Filler Injection

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maxigen Biotech Inc.: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan (r.o.c.), 100, Taiwan

Location

Tri-Service General Hospital

Taoyuan, Taiwan (r.o.c.), 33383, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2023
• First Posted: July 7, 2023
• Study Start: August 4, 2020
• Primary Completion: November 26, 2020
• Study Completion: June 24, 2021
• Last Updated: May 9, 2025

Record last verified: 2023-06

Locations

TW (2)