Safety Evaluation of Aline HA
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: October 12, 2012
Last updated: March 6, 2014
Last verified: March 2014
The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as determined by clinical assessment of treatment sites and routine tracking of adverse events.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety Evaluation of Aline HA|
Further study details as provided by TauTona Group:
Primary Outcome Measures:
- Safety Evaluation of Aline HA [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.
Secondary Outcome Measures:
- Safety Evaluation of Aline HA [ Time Frame: 6 months ] [ Designated as safety issue: No ]Secondary endpoints include an independent reviewer (IR) and the investigator's assessment of wrinkle severity score (WSS), if the NLF is treated, and; qualitative patient and investigator standardized questionnaires using the Global Aesthetic Improvement Scale (GAIS) if an area besides the NLF is treated.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: Dermal Filler - Aline HA
Single armed study
Device: Aline HA
Implantable dermal filler
Contacts and Locations