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.
Other Name: EVOLENCE
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.