The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Maxigen Biotech Inc.
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Immediately Pain Score Using Visual Analog Pain Scale(VAS)
Overview
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:
- The pain score assessed using Visual Analog Pain Scale(VAS) and Thermometer Pain Scale(TPS).
- The facial wrinkle assessed using Wrinkle Severity Rating Scales(WSRS).
- The treatment improvement assessed using Global Aesthetic Improvement Scale (GAIS).
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Immediately Pain Score Using Visual Analog Pain Scale(VAS)
Time Frame: immediately after injection
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).
Secondary Outcomes
- Pain Score Using Visual Analog Pain Scale(VAS)(15, 30, 45, 60 minutes after injection)
- Wrinkle Severity Rating Scales(WSRS) improvement ratio(Baseline, Day 14, Day 30)
- Incidence of Treatment-related Adverse Events(Day 0 to Day 30)
- Pain Score Using Thermometer Pain Scale(TPS)(immediately after injection)
- GAIS score assessed by physician(Day 14, Day 30)
- GAIS score assessed by subjects(Day 14, Day 30)