Dermal FillersNCT05935449
The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
A study testing Formaderm Lidocaine and Formaderm Dermal Filler Injection in people with Dermal Fillers and Lidocaine, run by Maxigen Biotech Inc. at 2 sites in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Dermal Fillers, Lidocaine, Hyaluronic Acid
- What is being tested?
- Formaderm Lidocaine and Formaderm Dermal Filler Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesTaiwan
- Study dates
- 4 Aug 2020to 24 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, Taiwan (r.o.c.), 100
Tri-Service General Hospital
Taoyuan City, Taiwan (r.o.c.), 33383
About this study
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.
Read more
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.
Read the 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
- Being tested
- Formaderm Lidocaine, Formaderm Dermal Filler Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formaderm LidocaineDevice
Dermal filler injection to facial areas
Formaderm Dermal Filler InjectionDevice
Dermal filler injection to facial areas
| Study group | Role | What they receive |
|---|---|---|
| Formaderm Lidocaine | Experimental | Formaderm Lidocaine was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c. Receives: 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. Receives: Device: Formaderm Dermal Filler Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: immediately after injection
Secondary outcomes (6)
Pain Score Using Visual Analog Pain Scale(VAS)
Assess the pain score after 15, 30, 45, 60 minutes of 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).
Measured: 15, 30, 45, 60 minutes after injection
Pain Score Using Thermometer Pain Scale(TPS)
Assess the pain score by the physician according to subjects' response immediately after application of Formaderm Lidocaine and Formaderm Dermal Filler Injection(without Lidocaine) at nasolabial fold. Thermometer Pain Scale(TPS) is scored from 0= no pain, to 10= worst possible pain.
Measured: immediately after injection
Wrinkle Severity Rating Scales(WSRS) improvement ratio
Based on the photographs, blinded physician rated the score of WSRS (Wrinkle Severity Rating Scales) for both group respectively. The difference of WSRS between baseline and day 14 and 30 were calculated. A positive value indicated "effective" improvement; while a value of 0 or a negative value was regarded as "ineffective" treatment. And the WSRS improvement ratio was defined as the effective improvement ratio of either group.
The WSRS is a 5-grade instrument for facial wrinkle, Grade 1(absent, no visible nasolabial fold;continuous skin line ) to Grade 5(extreme, extremely deep and long nasolabial fold, detrimental to facial appearance;2-4mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone)
Measured: Baseline, Day 14, Day 30
GAIS score assessed by physician
Compared with the baseline photographs, blinded physician rated the class of GAIS(Global Aesthetic Improvement Scale) on Day 14 and Day 30 from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group respectively.
Measured: Day 14, Day 30
GAIS score assessed by subjects
Compared with the baseline photographs, the subjects rated the class of GAIS(Global Aesthetic Improvement Scale) on Day 14 and Day 30 from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group respectively.
Measured: Day 14, Day 30
Incidence of Treatment-related Adverse Events
The adverse events are defined as any unfavorable sign occurrence in a subject after treatment. The investigator assesses the severity and the relationship of each event to the use of the study device.
Measured: Day 0 to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start4 Aug 2020
- Primary completion26 Nov 2020
- Study completion24 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermal FillersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maxigen Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935449
- Sponsor's protocol ID
- 0176TC10
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
- ClinicalTrials.gov ID
- NCT05935449
- Acronym / sponsor ID
- 0176TC10
- Conditions
- Dermal Fillers, Lidocaine, Hyaluronic Acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Maxigen Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 24 Jun 2021 (actual)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formaderm Lidocaine | Experimental | Device: Formaderm LidocaineFormaderm Lidocaine was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c. |
| Formaderm Dermal Filler Injection | Active comparator | Device: Formaderm Dermal Filler InjectionFormaderm Dermal Filler Injection was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Formaderm LidocaineDermal filler injection to facial areas | Device | Formaderm Lidocaine |
| Formaderm Dermal Filler InjectionDermal filler injection to facial areas | Device | Formaderm Dermal Filler Injection |
Primary outcome
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).
6 secondary outcomes
Pain Score Using Visual Analog Pain Scale(VAS)
Time frame: 15, 30, 45, 60 minutes after injection
Pain Score Using Thermometer Pain Scale(TPS)
Time frame: immediately after injection
Wrinkle Severity Rating Scales(WSRS) improvement ratio
Time frame: Baseline, Day 14, Day 30
GAIS score assessed by physician
Time frame: Day 14, Day 30
GAIS score assessed by subjects
Time frame: Day 14, Day 30
Incidence of Treatment-related Adverse Events
Time frame: Day 0 to Day 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formaderm Lidocaine and Formaderm Dermal Filler Injection in people with Dermal Fillers and Lidocaine, run by Maxigen Biotech Inc. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediately Pain Score Using Visual Analog Pain Scale(VAS) (time frame: immediately after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.