An Evaluation of an Injectable Material for Correction of Wrinkles
The objective of this study is to determine the effectiveness of a filler in improving wrinkles.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Evaluation of the Safety and Efficacy of Calcium Hydroxylapatite (Radiesse®) Injection in the Correction of Jowl-Associated Chin Notches|
- Correction of wrinkles [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Development of adverse events [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||February 2009|
|Estimated Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
subjects will receive filler injections
Device: Calcium Hydroxylapatite injection
Other Name: Radiesse
The primary objective of this study is to determine whether focal injection of calcium hydroxylapatite (Radiesse®), an injectable biodegradable filler, into jowl-induced chin notches can result in safe, aesthetically pleasing, and long-lasting correction of these.