Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds
This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Multicenter Comparison of the Safety and Efficacy of CosmetaLife™ Versus Control for the Correction of Nasolabial Folds|
- Change in Wrinkle Severity Rating Scale [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]To determine if the mean change in the 5-point Wrinkle Severity Rating Scale (WSRS) score at 6 months was non-inferior to the contralateral Control Restylane treated side, where on this 5-point scale 1 has no measurable nasolabial fold, 2 has some fold, 3 has moderate fold, 4 has heavier moderate fold, and a 5 has deep to a very deep nasolabial fold. For this study only moderate nasolabial folds were included (i.e., 3 or 4), where subjects scored as 5 were excluded.
- Adverse Event Reporting [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Safety and Effectiveness of CosmetaLife at 3, 9 and 12 Months [ Time Frame: 3, 9 and 12 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Test Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator.
Active Comparator: Restylane
Control Article was given at start and two week follow up if necessary, up to a maximum dose of 2 cc to achieve optimal correction as determined by investigator.
Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.
|United States, California|
|Tracy, California, United States, 95376|
|United States, Georgia|
|North Atlantic Plastic and Reconstructive Surgery|
|Roswell, Georgia, United States, 30076|
|United States, Massachusetts|
|SkinCare Physicians of Chestnut Hill|
|Chestnut Hill, Massachusetts, United States, 02467|
|United States, Minnesota|
|Cosmetic Care Center, LLC|
|Edina, Minnesota, United States, 55424|
|Minnesota Clinical Study Center|
|Fridley, Minnesota, United States, 55432|
|Study Director:||David B. Masters, Ph.D.||Cosmeta™ Corp|