Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00797459|
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : February 21, 2011
Last Update Posted : September 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Nasolabial Folds||Device: Restylane and Restylane-L||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||March 2009|
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.
- Treatment Difference in Pain as Measured by a Visual Analogue Scale [ Time Frame: After Injection on Day of Treatment ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797459
|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|