This will be a single-center, randomized, evaluator-blinded, split-face clinical study design. Fifty patients will receive one treatment session consisting of Restylane® Silk (right side of the face) and Belotero Balance® (left side), or vice versa (1:1 dose conversion ratio) injections to the superficial, vertical perioral lines. Injections will be performed at the baseline visit. To ensure subject and investigator blinding, syringes will be prepared and labeled "1" and "2" immediately before subject attendance for injection by the sub-investigator. The same injection sites and techniques will be used on both sides of the face. Then, patients will follow-up on post-treatment day 7, 14, 30, 60, 90, 120, 150, 180.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
The Maas Clinic
San Francisco, California, United States
RECRUITINGChange in Response to therapy as evaluated by investigator using 5-point Merz® Scale
Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded evaluator: A 1-point improvement from baseline in superficial, vertical, perioral rhytids based on the 5-point Merz® Scale
Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Response to Therapy- Subject
Response to therapy on each side of the lip on day 0 (initial treatment), and subsequent post-treatment days 7, 14, 30, 60, 90, 120, 150, 180, as measured by the blinded patient: A 20% improvement from baseline in superficial, vertical, perioral rhytids using a linear analog scale
Time frame: Day 0, 7, 14, 30, 60, 90, 120, 150, 180
Severity grading- Evaluator
Severity grading by a blinded evaluator employing standardized photography in combination with the 5-point Merz® Scale
Time frame: 6 months
VISIA complexion analysis
VISIA complexion analysis (Canfield Imaging Systems, Fairfield, New Jersey) on day 0 (initial treatment), day 30 and when the patient's perioral fine lines have returned to baseline. VISIA analysis will be used to grade the patient's skin by measuring the wrinkles and generating a percentile score.
Time frame: Day 0, Day 30
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