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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:
Participants will be self-controlled and randomized for same period,
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formaderm Lidocaine | Experimental | Formaderm 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 | Formaderm Dermal Filler Injection was randomly administered either side of subjects' facial areas once.The injection volume was limited to 2c.c. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formaderm Lidocaine | Device | Dermal filler injection to facial areas |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 15, 30, 45, 60 minutes after injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan (r.o.c.) | 100 | Taiwan | ||
| Tri-Service General Hospital |
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| Formaderm Dermal Filler Injection |
| Device |
Dermal filler injection to facial areas |
|
| 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. | 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) | 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. | 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. | 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. | Day 0 to Day 30 |
| Taoyuan City |
| Taiwan (r.o.c.) |
| 33383 |
| Taiwan |