Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.
This was a study to find out how an investigational product, Belotero, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkles on the face that go from the outside of the nostrils to the edges of the mouth. Additionally, this study determined Belotero is safe and tolerable and corrects facial wrinkles, such as nasolabial folds.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Blinded, Controlled, Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®, After Mid-to-Deep Dermal Implantation for Correction of Moderate to Severe Facial Wrinkles|
- Adjusted (LS) Mean Change From Baseline in Wrinkle Severity Rating Scale (SRS) Score of Each Nasolabial Fold (NLF) as Determined by the Blinded Evaluator at Week 12. [ Time Frame: Baseline and Week 12 of follow-up ] [ Designated as safety issue: No ]The severity of the nasolabial folds was measured using the wrinkle Severity Rating Scale (SRS), where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, and 4 = Extreme, which is an ordinal scale.
|Study Start Date:||December 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Belotero, injectable hyaluronic acid gel device, implanted into the nasolabial fold in the Treatment Phase of the study (multiple injections of 0.1 to 0.2 mL, up to a maximum of 3 mL over 2 treatment sessions). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered.
|Active Comparator: Zyplast||
Zyplast Collagen Implant, an injectable dermal collagen device, implanted into the nasolabial fold in the Treatment Phase of the study (average injection of 1.0 mL). Dose was based on the severity of the wrinkle, with a maximum dose to achieve 100% correction to be administered. Zyplast was obtained by each site from commercially available supplies.
|United States, Alabama|
|Total Skin and Beauty Dermatology Center|
|Birmingham, Alabama, United States, 35205|
|United States, California|
|Skin Care & Laser Physicians of Beverly Hills|
|Los Angeles, California, United States, 90069|
|San Francisco, California, United States, 94115|
|United States, Connecticut|
|New Haven, Connecticut, United States, 06511|
|United States, Louisiana|
|William Coleman, III, MD|
|Metairie, Louisiana, United States, 70006|
|United States, New York|
|Dermatology Surgery and Laser Center|
|White Plains, New York, United States, 10604|
|Principal Investigator:||Rhoda Narins, MD||Dermatology Surgery and Laser Center|