This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
145
Dermal filler
Dermal filler
Beauty Renewed
Tracy, California, United States
North Atlantic Plastic and Reconstructive Surgery
Roswell, Georgia, United States
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States
Cosmetic Care Center, LLC
Edina, Minnesota, United States
Change in Wrinkle Severity Rating Scale
To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.
Time frame: baseline and 6 months
Adverse Event Reporting
Time frame: 6 months
Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months
Time frame: 3, 9 and 12 months
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Minnesota Clinical Study Center
Fridley, Minnesota, United States