Safety Evaluation of Aline HA

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TauTona Group
ClinicalTrials.gov Identifier:
NCT01708213
First received: October 12, 2012
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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 Intervention
Correction of Wrinkles
Device: Aline HA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Evaluation of Aline HA

Further study details as provided by TauTona Group:

Primary Outcome Measures:
  • Safety Evaluation of Aline HA [ 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.


Secondary Outcome Measures:
  • Safety Evaluation of Aline HA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Secondary endpoints include an independent reviewer (IR) and the investigator's assessment of wrinkle severity score (WSS), if the NLF is treated, and; qualitative patient and investigator standardized questionnaires using the Global Aesthetic Improvement Scale (GAIS) if an area besides the NLF is treated.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermal Filler - Aline HA
Single armed study
Device: Aline HA
Implantable dermal filler

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708213

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
  More Information

No publications provided

Responsible Party: TauTona Group
ClinicalTrials.gov Identifier: NCT01708213     History of Changes
Other Study ID Numbers: CP 10664
Study First Received: October 12, 2012
Last Updated: March 6, 2014
Health Authority: Canada: Health Canada

Keywords provided by TauTona Group:
soft tissue
augmentation
correction
wrinkles

ClinicalTrials.gov processed this record on April 21, 2014