Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
Dermatology Research Institute LLC
Coral Gables, Florida, United States
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, United States
The Center for Dermatology, Cosmetic and Laser Surgery
Mount Kisco, New York, United States
Treatment Difference in Pain as Measured by a Visual Analogue Scale
No pain is noted at 0 mm and worst pain is noted at 100 mm.
Time frame: After Injection on Day of Treatment
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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