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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
155
Injection of TEOSYAL® TPVM at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
Injection of a COMPARATOR at Baseline Optional Touch-up treatment at 4 weeks if needed to achieve optimal correction as judged by the PI.
Care- Geneva
Geneva, Switzerland
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"
Time frame: 8 weeks
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