- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05935449
The Clinical Trial of Difference Between Formaderm Lidocaine and Formaderm Dermal Filler Injection
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Taiwan (r.o.c.)
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Taipei City, Taiwan (r.o.c.), Taiwan, 100
- National Taiwan University Hospital
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Taoyuan City, Taiwan (r.o.c.), Taiwan, 33383
- TRI-Service General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Formaderm Lidocaine
Formaderm Lidocaine was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c.
|
Dermal filler injection to facial areas
|
Active Comparator: 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.
|
Dermal filler injection to facial areas
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
immediately after injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score Using Visual Analog Pain Scale(VAS)
Time Frame: 15, 30, 45, 60 minutes after injection
|
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).
|
15, 30, 45, 60 minutes after injection
|
Pain Score Using Thermometer Pain Scale(TPS)
Time Frame: immediately after injection
|
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.
|
immediately after injection
|
Wrinkle Severity Rating Scales(WSRS) improvement ratio
Time Frame: Baseline, Day 14, Day 30
|
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) |
Baseline, Day 14, Day 30
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GAIS score assessed by physician
Time Frame: Day 14, Day 30
|
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.
|
Day 14, Day 30
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GAIS score assessed by subjects
Time Frame: Day 14, Day 30
|
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.
|
Day 14, Day 30
|
Incidence of Treatment-related Adverse Events
Time Frame: Day 0 to Day 30
|
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.
|
Day 0 to Day 30
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 0176TC10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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