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

Nasolabial Folds Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778531
• Other study ID #: Protocol 521-01
• Secondary ID: D82-3002-07
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2008
• Last updated: November 18, 2014
• Start date: September 2007
• Est. completion date: February 2014

Study information

• Verified date: November 2014
• Source: Suneva Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1008
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Nasolabial Folds

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Suneva Medical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		5 years	Yes
Secondary	The subject's assessment of satisfaction will be characterized using a non-parametric five-point scale at each follow-up period.		5 years	No