Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device
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:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Multi-center, Open-label, Prospective Study of Implanted Cross-linked HA Device, Aline HA, for Soft Tissue Augmentation, to Treat Only One Anatomic Feature in up to 100 Subjects for 6 Months|
- Assessment of Treatment Site Responses Post Procedure [ 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.
- Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds [ Time Frame: 6 months ] [ Designated as safety issue: No ]
For this study, a decrease (at least one point) in the rating, relative to pre-treatment rating, when assessed by Investigators at the 1-Month, 3-Month, and 6-Month visits was considered clinically significant (P value less than 0.05).
(0) - No wrinkle
- - Just perceptible wrinkle
- - Shallow wrinkle
- - Moderately deep wrinkle
- - Deep wrinkle, well-defined edges
- - Very deep wrinkle, redundant fold
- Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS [ Time Frame: 6 months ] [ Designated as safety issue: No ]This was measured using the Global Aesthetic Improvement Scale (GAIS). With the Global Aesthetic Improvement Scale (GAIS Scale) results of 1, 2 and 3 at 6 months were considered satisfied in this study.
|Study Start Date:||October 2012|
|Study Completion Date:||December 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: Dermal Filler - Aline HA
Single armed study
Device: Aline HA
Implantable dermal filler
A multi-center, open-label, prospective study of implanted cross-linked HA device, Aline HA, for soft tissue augmentation, to treat only one anatomic feature in up to 100 subjects for 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708213
|Dr. Nowell Solish|
|Toronto, Ontario, Canada, M5R3N8|
|The Westmount Institute of Plastic Surgery|
|Montreal, Quebec, Canada, H3Z1B7|
|Principal Investigator:||Nowell Solish, MD|