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Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emervel Classic | Experimental | Subjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling. |
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| Emervel Deep | Experimental | Subjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emervel Classic | Device | Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3) |
| Measure | Description | Time Frame |
|---|---|---|
| Subject-reported time of return to social engagement after initial treatment | Time of return to social engagement (in hours) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to post-treatment follow-up time points in subject reported GAIS | Change from baseline to post-treatment follow-up time points in the subject reported GAIS (photographs) at day 30 | up to 30 days |
| Subject satisfaction with treatment outcome of the nasolabial folds |
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Key Inclusion Criteria:
Childbearing potential is defined as not being surgically sterile (e.g., hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or those who are not post-menopausal (absence of menstruation for at least 1 year prior to Day 1).
- If not surgically sterile or post-menopausal, the subject agrees to use acceptable forms of contraception. Acceptable methods of contraception are defined as follows:
Females of child bearing potential must have negative urine pregnancy test (UPT) at Day 1 and Day 14 if touch-up is to be performed.
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Author Swift, MD | Arthur Swift Research Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur Swift Research Inc. | Montreal | Quebec | H3Z 1B7 | Canada |
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| Emervel Deep | Device | Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4). |
|
Subject satisfaction with treatment assessments at baseline, day 14, and day 30 |
| 30 days |
| Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS | Change from baseline to post-treatment follow-up time points in the treating investigator reported WSRS at day 14 and day 30 | 30 days |
| Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS | Change from baseline to post-treatment follow-up time points in the treating investigator reported GAIS (photographs) at day 30 | 30 days |
| Incidence rate of subjects with adverse events (AEs) | 30 days |
| Incidence rate of subjects with injection-related adverse events | Injection-related adverse events recorded by the subject in study diary | 30 days |