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

• ClinicalTrials.gov Identifier: NCT01708213
• Recruitment Status: Completed
• First Posted: October 16, 2012
• Results First Posted: December 17, 2014
• Last Update Posted: December 17, 2014
• Sponsor: TauTona Group
• Information provided by (Responsible Party): TauTona Group

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Disorder of Soft Tissue	Device: Aline HA	Not Applicable

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 72 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: October 2012
• Actual Primary Completion Date: November 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dermal Filler - Aline HA; Single armed study	Device: Aline HA; Implantable dermal filler

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

   1. - Just perceptible wrinkle
   2. - Shallow wrinkle
   3. - Moderately deep wrinkle
   4. - Deep wrinkle, well-defined edges
   5. - Very deep wrinkle, redundant fold
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. The patient must be ≥ 21 and ≤ 70 years of age.
2. The patient must be willing and able to provide informed consent.
3. The patient must be able to read.
4. The patient is willing and able to comply with the study protocol.
5. The patient is seeking soft tissue augmentation
6. The patient has a pre-treatment Wrinkle Severity Score (WSS) ≥ 2 for any NLF to be treated.
7. 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:

  1. 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.
  2. Laser or light based therapy that would affect the treatment area within the last 6 months.
  3. 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.
  4. Non-permanent dermal filler treatment in the treatment area within the last 9 months.
  5. Permanent implant or dermal filler treatment in the treatment area at any point in time.
  6. Neurotoxin treatment that would affect the treatment area in the last 6 months, if the treatment area is below the eyes.

  7. 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.

Contacts and Locations

Locations

Canada, Ontario

Dr. Nowell Solish

Toronto, Ontario, Canada, M5R3N8

Canada, Quebec

The Westmount Institute of Plastic Surgery

Montreal, Quebec, Canada, H3Z1B7

Sponsors and Collaborators

TauTona Group

Investigators

• Principal Investigator: Nowell Solish, MD

More Information

• Responsible Party: TauTona Group
• ClinicalTrials.gov Identifier: NCT01708213
• Other Study ID Numbers: CP 10664
• First Posted: October 16, 2012
• Results First Posted: December 17, 2014
• Last Update Posted: December 17, 2014
• Last Verified: December 2014

Keywords provided by TauTona Group:

soft tissue; augmentation; correction; wrinkles