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The clinical study is designed to prospectively evaluate the safety and effectiveness of TEOSYAL® TPVM when compared to COMPARATOR for the remodeling of the lower face
This is a prospective, randomized, blinded evaluator, multicenter, clinical study to evaluate safety and effectiveness of TEOSYAL® TPVM versus COMPARATOR for the remodeling of the lower face.
Subject will be enrolled in the study based on evaluation of their chin retrusion severity.
For the purpose of this study, all injections will be done by principal investigators (PIs) with several years of experience in aesthetic treatment.
An external aesthetic and cosmetic surgeon will act as a BE to assess the performance of the treatment and the product based on photographs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEOSYAL® TPVM | Experimental | n=116 subjects |
|
| COMPARATOR | Active Comparator | n= 39 subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEOSYAL® TPVM | Device | Injection of TEOSYAL® TPVM at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in TCRS score between Baseline and 8 weeks after last treatment as assessed by the Blinded Evaluator | Non-inferiority of TCRS score change from Baseline for subjects treated with TEOSYAL TPVM compared to subjects treated with a COMPARATOR at 8 weeks after last treatment as assessed by the BE. TCRS (Teoxane Chin Retrusion Scale) is a validated 4-point scale assessing chin retrusion severity with 0 being "None/minimal" and 3 being "Severe" | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Care- Geneva | Geneva | Switzerland |
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| COMPARATOR | Device | Injection of a COMPARATOR at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI. |
|