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To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YVOIRE volume s | Treatment with YVOIRE volume s |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YVOIRE volume s | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Device-related Adverse Events | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Subject who receive hyaluronic acid filler into the nasolabial folds
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| ID | Title | Description |
|---|---|---|
| FG000 | YVOIRE Volume s | YVOIRE volume s YVOIRE volume s |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | YVOIRE Volume s | YVOIRE volume s YVOIRE volume s |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Device-related Adverse Events | Posted | Count of Participants | Participants | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years |
|
|
Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | YVOIRE Volume s | YVOIRE volume s YVOIRE volume s | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast disease | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Leader | LG Chem | 82-2-6987-4148 | sodam@lgchem.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 7, 2015 | Nov 27, 2018 | Prot_SAP_000.pdf |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| 503 |
| 20 |
| 503 |
| 115 |
| 503 |
| Others | General disorders | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
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