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This is a prospective, multi-center, randomized, controlled, subject- and evaluator-blinded clinical investigation to demonstrate non-inferiority of TEOSYAL® PureSense ULTRA DEEP compared to Restylane® Lidocaine for the correction of moderate to severe NLF in Chinese adults.
Eligible subjects will be enrolled and randomized either to the treatment group or control group in a 1:1 ratio on Day 0. Each subject assigned to the treatment group will receive TEOSYAL® PureSense ULTRA DEEP in both NLFs, whereas subjects assigned to the control group will receive Restylane® Lidocaine.
The treating investigator will administer the corresponding product in both NLFs of the subject on Day 0.
All subjects will return to the site at 4, 12, 24, 36, and 52 weeks after the last treatment for effectiveness and safety assessment. All subjects will receive a safety phone call 7 days after the initial treatment at baseline, and after the touch-up treatment, if applicable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultra Deep | Experimental |
| |
| Restylane | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection in NLF | Device | TEOSYAL® PureSense ULTRA DEEP is a sterile, transparent, non-pyrogenic, viscoelastic gel made of HA of non-animal origin |
|
| Measure | Description | Time Frame |
|---|---|---|
| WSRS grading | Proportion of responders, defined by at least 1-point improvement from baseline 5-point WSRS, as measured by the blinded live evaluator at 24 weeks after the last treatment | 24 weeks after last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elise Gondard | Contact | +41 22 344 96 36 | e.gondard@teoxane.com | |
| Sophie Delhomme | Contact | +41798552342 | s.delhomme@teoxane.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Second Provincial General Hospital | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Blinded-Live evaluator