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

NCT01708213 | Completed Results DMC

• 1 other identifier: CP 10664
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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.

Conditions

Disorder of Soft Tissue

Keywords

soft tissue; augmentation; correction; wrinkles

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With a Decrease in the Wrinkle Severity Scale for Nasolabial Folds

  6 months

• Percentage of Participants That Were Satisfied With the Treatment as Rated by GAIS

  6 months

Study Arms (1)

Dermal Filler - Aline HA

EXPERIMENTAL

Single armed study

Device: Aline HA

Interventions

Aline HA DEVICE

Implantable dermal filler

Dermal Filler - Aline HA

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \) 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.
• \) The patient has a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area in the last 24 months.
• \) 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.
• \) 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.
• \) 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.

Sponsors & Collaborators

• TauTona Group: lead

Study Sites (2)

Dr. Nowell Solish

Toronto, Ontario, M5R3N8, Canada

Location

The Westmount Institute of Plastic Surgery

Montreal, Quebec, H3Z1B7, Canada

Location

Results Point of Contact

• Title: Ann Thomas
• Organization: TauTona Group

athomas@tautonagroup.com

650-331-2461

Study Officials

• Nowell Solish, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 17, 2014
• Results First Posted: December 17, 2014

Record last verified: 2014-12

Locations

CA (2)