Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
Safety & tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Treatment Difference in Pain as Measured by a Visual Analogue Scale [ Time Frame: After Injection on Day of Treatment ] [ Designated as safety issue: No ]No pain is noted at 0 mm and worst pain is noted at 100 mm.
- Wrinkle Improvement at Day 14 [ Time Frame: 14 days after treatment when compared to baseline ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2008|
|Study Completion Date:||March 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Restylane and Restylane with Lidocaine
This is a split-face design injecting both Restylane and Restylane-L injectable gels, administered once. Each subject received Restylane on one side of the face, and Restylane-L on the other. Subjects were blinded to which side of their face received Restylane or Restylane-L. The study was randomized and treatments successive.
Device: Restylane and Restylane-L
This is a split face design and each subject received both Restylane and Restylane-L. Treatments were double blind, randomized, and successive.
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
|United States, Florida|
|Dermatology Research Institute LLC|
|Coral Gables, Florida, United States, 33146|
|United States, Maryland|
|Maryland Laser Skin and Vein Institute|
|Hunt Valley, Maryland, United States, 21030|
|United States, New York|
|The Center for Dermatology, Cosmetic and Laser Surgery|
|Mount Kisco, New York, United States, 10549|
|Principal Investigator:||David Bank, MD||The Center for Dermatology, Cosmetic and Laser Surgery|
|Principal Investigator:||Fredric Brandt, MD||Dermatology Research Institute LLC|
|Principal Investigator:||Robert Weiss, MD||Maryland Laser Skin and Vein Institute|
|Study Director:||Ron Staugaard||Medicis Pharmaceutical|