Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
This is a split-face design. All 60 subjects receive Perlane on one side of their face, and Perlane-L on the other. Subjects and the investigator is blinded to which side of face receives which product. These are one time injections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.
Unnamed facility
Coral Gables, Florida, United States
Unnamed facility
Hunt Valley, Maryland, United States
Unnamed facility
Mount Cisco, New York, United States
Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm
Time frame: After Injection on Day of Treatment
Number of Subjects Showing Wrinkle Improvement at Day 14
This measure was performed by the validated GAIS tool (Global Asthetic Improvement Scale). The GAIS was completed by the participant at day 14. The GAIS is a qualitative 5 point scale evaluating Aesthetic Improvement (0=worse, 1=no change, 2=Improved, 3=Much Improved, 4=very much improved). Treatment success is defined as at least a one grade improvement (2, 3, or 4) from pre-treatment.
Time frame: 14 days after treatment when compared to baseline
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