- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01708213
Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5R3N8
- Dr. Nowell Solish
-
-
Quebec
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Montreal, Quebec, Canada, H3Z1B7
- The Westmount Institute of Plastic Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient must be ≥ 21 and ≤ 70 years of age.
- The patient must be willing and able to provide informed consent.
- The patient must be able to read.
- The patient is willing and able to comply with the study protocol.
- The patient is seeking soft tissue augmentation
- The patient has a pre-treatment Wrinkle Severity Score (WSS) ≥ 2 for any NLF to be treated.
- The patient agrees to follow-up examinations out to 6 months post final treatment.
Exclusion Criteria:
Exclusion Criteria: 1) The patient has had (or plans to have) cosmetic procedures to treat the intended treatment area, such as:
- Ablative or non-ablative resurfacing procedures including but not limited to medium depth or deeper chemical peeling, dermabrasion, laser resurfacing or fractional resurfacing that would affect the treatment area within the last 12 months.
- Laser or light based therapy that would affect the treatment area within the last 6 months.
- Face, neck or brow lift or other surgical procedure of the head and neck that would affect the treatment area in the last 18 months.
- Non-permanent dermal filler treatment in the treatment area within the last 9 months.
- Permanent implant or dermal filler treatment in the treatment area at any point in time.
- Neurotoxin treatment that would affect the treatment area in the last 6 months, if the treatment area is below the eyes.
Neurotoxin treatment that would affect the treatment area in the last 9 months, if the treatment area is above the eyes.
2) The patient has had or plans to use a pharmaceutical (topical or oral) anti-wrinkle product or other products (e.g., topical retinoids, hormone creams) affecting inflammation in the treatment area within 30 days of the study 3) The patient has inflammatory or infectious skin conditions or unhealed wounds in the treatment areas.
4) The patient has a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area in the last 24 months.
5) The patient has a history of anaphylaxis, multiple severe allergies, atopy, or is allergic to lidocaine or amide-based anesthetics, hyaluronic acid products, Streptococcal proteins or proteins from other gram positive organisms.
6) The patient has a history of significant bleeding disorders. 7) The patient has scleroderma or fibrotic tissue disease. 8) The patient is female and of child bearing potential and/or is pregnant or lactating or is not using medically effective birth control, such as hormonal methods in use at least 30 days prior to implantation, or barrier methods such as a condom and spermicide in use at least 14 days prior to implantation.
9) The patient is using a Legally Authorized Representative. 10) The patient is an employee or employee's family member of either the Study Sponsor or a Study Site.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dermal Filler - Aline HA
Single armed study
|
Implantable dermal filler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of Treatment Site Responses Post Procedure
Time Frame: 6 months
|
The primary endpoint of this study is to assess treatment site responses and adverse events through 6 months post procedure.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds
Time Frame: 6 months
|
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
|
6 months
|
Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nowell Solish, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CP 10664
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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