Clinical trial NCT05935449: The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
Official title: The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermal Fillers
Lidocaine
Hyaluronic Acid
Lead sponsor: Maxigen Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-07
Enrollment: 42
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Immediately Pain Score Using Visual Analog Pain Scale(VAS)
timeFrame: immediately after injection
Secondary outcomes:
measure: Pain Score Using Visual Analog Pain Scale(VAS)
timeFrame: 15, 30, 45, 60 minutes after injection
measure: Pain Score Using Thermometer Pain Scale(TPS)
timeFrame: immediately after injection
measure: Wrinkle Severity Rating Scales(WSRS) improvement ratio
timeFrame: Baseline, Day 14, Day 30
measure: GAIS score assessed by physician
timeFrame: Day 14, Day 30
measure: GAIS score assessed by subjects
timeFrame: Day 14, Day 30
measure: Incidence of Treatment-related Adverse Events
timeFrame: Day 0 to Day 30
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
state: Taiwan (R.O.C.)
city: Taoyuan City
country: Taiwan
facility: Tri-Service General Hospital
state: Taiwan (R.O.C.)
Study officials:
References: