Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Disorder of Soft Tissue

Intervention / Treatment
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* Device: Aline HA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dermal Filler - Aline HA<br>Single armed study | Device: Aline HA<br>* Implantable dermal filler<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 - Just perceptible wrinkle - Shallow wrinkle - Moderately deep wrinkle - Deep wrinkle, well-defined edges - Very deep wrinkle, redundant fold | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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soft tissue, augmentation, correction, wrinkles