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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Implantable dermal filler
Dr. Nowell Solish
Toronto, Ontario, Canada
The Westmount Institute of Plastic Surgery
Montreal, Quebec, Canada
Assessment of Treatment Site Responses Post Procedure
The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.
Time frame: 6 months
Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds
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). WSS: (0) - No wrinkle 1. \- Just perceptible wrinkle 2. \- Shallow wrinkle 3. \- Moderately deep wrinkle 4. \- Deep wrinkle, well-defined edges 5. \- Very deep wrinkle, redundant fold
Time frame: 6 months
Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS
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.
Time frame: 6 months
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