Primary Outcome Measures:
- To assess the safety EVOLENCE® in subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of facial wrinkles in accordance with the
approved device labeling including for example correction of the nasolabial wrinkle /folds. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the device effectiveness in skin types IV, V, and VI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Intervention Details:
Drug: EVOLENCE
Subjects, who fulfill all eligibility criteria, will be injected with EVOLENCE® to treat their wrinkles and folds of the nasolabial area (both sides) in accordance with the approved device labeling. Within two weeks after initial injection, a visit will be performed to evaluate if Optimal Cosmetic Result (OCR) is achieved per PI discretion. If OCR is achieved the subject will start the follow-up period of the study. If OCR has not been achieved following the initial injection, additional 'touch-up' injections may be performed. The subject will be injected as much as needed until OCR is achieved as per PI discretion.
The Primary objective of this study is to assess the safety EVOLENCE® in subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of facial wrinkles in accordance with the approved device labeling including for example correction of the nasolabial wrinkle /folds.