Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose
Safety study that compares Perlane to Perlane with Lidocaine while correcting wrinkles in the area around your nose.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind Study Comparing Safety and Tolerability of Perlane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds|
- Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm [ Time Frame: After Injection on Day of Treatment ] [ Designated as safety issue: No ]
- Number of Subjects Showing 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:||January 2009|
|Study Completion Date:||April 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Perlane and Perlane-L
This is a split-face design injecting both Perlane and Perlane-L injectable gels, administered once. Each subject received Perlane-L on one side of the face, and Perlane on the other. Subjects were blinded to which side of their face receive Perlane or Perlane-L. The study was randomized and treatments successive.
Device: Perlane and Perlane-L
This is a split face design and each subject received both Perlane-L and Perlane. Treatments were blinded, randomized, and successive.
Other Name: Each subject received both Perlane-L and Perlane.
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.
|United States, Florida|
|Coral Gables, Florida, United States|
|United States, Maryland|
|Hunt Valley, Maryland, United States|
|United States, New York|
|Mount Cisco, New York, United States|
|Study Chair:||Mary Sanstead||Medicis Global Pharmaceutical|