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The goal of this clinical trial is to evaluate the safety and efficacy of Formaderm Young Dermal Filler Injection, which is a hyaluronic acid dermal filler injected into the mid to deep dermis for the correction of moderate-to-severe nasolabial fold facial wrinkles.
The main questions it aims to answer are:
Participants will be blinded and randomized into either experiment group or control group, and re-visited on 1, 3, 6, 9 and 12 month after injection.
Researchers will compare if the test product is non-inferiority to Restylane.
A prospective, parallel, two-center, non-inferior, randomized, double-blind trial was conducted in this study. It was planned to recruit 157 subjects for each group, considering a 10% dropout rate that would lead to 320 subjects overall.
Subjects eligible in the screening will be enrolled. Each patient will receive the same treatment, either Formaderm Young Dermal Filler Injection or Restylane, to correct both sides of the nasolabial fold through randomization.
Clinical efficacy will be assessed by the blinded physician using the WSRS and GAIS, as well as by subjects using GAIS. The safety issue of Formaderm Young or Restylane will be identified and recorded during the course of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formaderm Young | Experimental | Formaderm Young was randomly administered to subjects. The injection volume was limited to 2c.c. |
|
| Restylane | Active Comparator | Restylane was randomly administered to subjects. The injection volume was limited to 2c.c. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formaderm Young | Device | Dermal filler injection to facial areas. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS improvement ratio at 6 month post-injection | The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 6 month post-injection. 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. | Baseline and 6 month post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| WSRS score | Blinded physician rated the score of WSRS(Wrinkle Severity Rating Scales) for both group respectively. 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Beijing | Chaoyang | 100029 | China | ||
| Beijing Tongren Hospital, Capital Medical University |
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| Restylane |
| Device |
Dermal filler injection to facial areas. |
|
| Baseline and 1 month, 3month, 6month post-injection |
| WSRS improvement ratio | The difference of WSRS(Wrinkle Severity Rating Scales) between baseline and 1 month and 3 month post-injection. 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. | Baseline, 1 month and 3month post-injection |
| GAIS score assessed by physician | Compared with the baseline photographs, blinded physician rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group at 1 month, 3 month and 6 month post-injection respectively. | Baseline, 1 month, 3month and 6month post-injection |
| GAIS score assessed by subjects | Compared with baseline, subjects themselves rated the class of GAIS(Global Aesthetic Improvement Scale) from 5(exceptional improvement, excellent corrective result) to 1(worsened patient, the appearance has worsened compared with the original condition) for both group at 1 month, 3 month and 6 month post-injection respectively. | Baseline, 1 month, 3month and 6month post-injection |
| 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. | Month 0 to month 12 |
| Beijing |
| Tongren |
| 100005 |
| China |