Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00778531
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
Suneva Medical, Inc.

Brief Summary:
The purpose of this post-approval study is to evaluate the continuing safety of ArteFill as an injectable implant for correction of nasolabial folds over the course of five years post implantation, with a focus on determining the incidence of granuloma formation. Incidence of adverse events and subject satisfaction with respect to the subject's personal expectations will be assessed.

Condition or disease Intervention/treatment Phase
Nasolabial Folds Device: ArteFill injectable implant Phase 4

Detailed Description:
This study is a multi-center, non-randomized, non-controlled post-approval study designed to follow a total of 1000 consecutive qualified and consenting subjects treated with ArteFill in the course of clinical practice at approximately twenty-five centers. All potential qualifying subjects at a given site should be given the opportunity to participate in the study. Inclusion and exclusion criteria will be limited to those in the approved labeling for ArteFill and treatment will be according to the approved product labeling. Subjects must have a previously documented negative skin test prior to treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1008 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Protocol for the Post-approval Study of ArteFill® for Correction of Nasolabial Folds
Study Start Date : September 2007
Primary Completion Date : February 2014
Study Completion Date : February 2014

Arm Intervention/treatment
single-arm study
This study was a multi-center, open-label, post-approval study
Device: ArteFill injectable implant
Treatment will be according to the approved labeling for ArteFill for the correction of nasolabial folds. The nasolabial fold is the line or fold that extends from approximately the inferior aspect of the ala of the nose to the commissure of the mouth on the right and left side of the face.

Primary Outcome Measures :
  1. The incidence of granuloma formation will be determined. The overall assessment of safety will be based on the incidence of serious unanticipated adverse events. Incidence of anticipated adverse events will be assessed at each follow-up period. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The subject's assessment of satisfaction will be characterized using a non-parametric five-point scale at each follow-up period. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subject is male or non-pregnant female 18 years of age or older.
  • Subject has provided written and verbal informed consent.
  • Subject is willing to comply with study instructions and return to the clinic for required visits.
  • Subject is willing to withhold additional aesthetic implant therapies to the NLF [e.g., other soft tissue fillers: Restylane, Silicone, Radiesse, Sculptra) or implants: gortex, silastic, thread lift, etc.] for the duration of the study.

Exclusion Criteria:

  • Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.
  • Subject has a history of systemic granulomatous diseases active or inactive (e.g.Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (.e.g., lupus,dermatomyositis, etc.).
  • Subject is immuno-compromised in the opinion of the investigator because of disease or medical therapy (e.g., HIV, use of chemotherapy, etc.)
  • Subject has been treated with any of the following in their NLF in the time intervals specified prior to the start of their participation in the study:

    • Bovine collagen - 6 months
    • Porcine or human collagen - one year
    • Hyaluronic acid - one year
    • Hydroxylapatite - one year
    • Autologous fat - at any time
    • Polymethylmethacrylate or other acrylates - at any time
    • Polyacrylamide - at any time
    • Polyethylene oxide - at any time
    • Polylactic acid - at any time
    • Liquid silicone - at any time
    • Other permanent implant material (FDA approved or not) - at any time
  • Subject has had the placement of any surgical implants in the NL folds region(e.g., Gortex, Silastic implants, thread lifts, etc.) at any time.
  • Subject has a history of multiple severe allergies or allergies manifested by anaphylaxis.
  • Subject has a history of allergy to lidocaine.
  • Subject has a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures.
  • The subject has known hypersensitivity or previous allergic reaction to any of the components of the study devices not previously mentioned.
  • Subject is undergoing or planning to undergo desensitization injections to meat products.
  • Subject has any condition which, in the Investigator's opinion, would make it unsafe for the subject to participate in this research study.
  • Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
  • Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.

Responsible Party: Suneva Medical, Inc. Identifier: NCT00778531     History of Changes
Other Study ID Numbers: Protocol 521-01
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Keywords provided by Suneva Medical, Inc.:
injectable implant
nasolabial folds
Correction of nasolabial folds

Additional relevant MeSH terms:
Polymethyl Methacrylate
Vasodilator Agents
Antimutagenic Agents
Protective Agents
Physiological Effects of Drugs