Open-Label Study to Evaluate the Immunogenicity of Bovine... | NCT00778089

Studies
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing

NCT00778089

Sponsor

Suneva Medical, Inc.

Status

Terminated

Last Update Posted

Sep 27, 2019Actual

Enrollment

498Actual

Phase

Not Applicable

Conditions

Hypersensitivity

Interventions

ArteFill® Skin Test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Closed incomplete due to Artes Medical Closing

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Dec 3, 2008Actual

Completion Date

Dec 3, 2008Actual

First Submitted Date

Oct 21, 2008

First Submission Date that Met QC Criteria

Oct 22, 2008

First Posted Date

Oct 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2019

Last Update Posted Date

Sep 27, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the clinical utility of the ArteFill® pre-treatment Skin Test in predicting and preventing hypersensitivity reactions to treatment with ArteFill® implant

Detailed Description

This is a single-center, open-label study in approximately 485 healthy male and female subjects to obtain 450 evaluable subjects. In this protocol, an ArteFill® Skin Test study will be conducted to evaluate the test's clinical utility to determine the incidence of positive skin reactions to ArteFill®. The results of this skin test study will determine if the risk of a hypersensitivity reaction against ArteFill® without a skin test is no greater than the published historical risk of a hypersensitivity reaction against a Zyderm or Zyplast treatment after a patient demonstrates a negative response to a single Zyderm skin test. Based on prior clinical experience with ArteFill® implant in commercial use outside the United States, it is anticipated that no reactions will be observed. As such, it may be suggested that there is no practical use of the ArteFill® Skin Test for screening patients, and therefore, the test may be eliminated as a requirement prior to treatment with the ArteFill® product as is the clinical practice outside the United States.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

498Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Open Label Single Arm	Other	All enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine.	Device: ArteFill® Skin Test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ArteFill® Skin Test	Device	Subjects will receive the ArteFill® Skin Test at Visit 1, Day 0 on the volar forearm. After 30 days, if the test result is negative a second skin test will be administered on the contra volar forearm at Visit, 3, Day 30.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.		60 days

Secondary Outcomes

Measure	Description	Time Frame
In addition to the primary outcome measure, to assist in assessing the etiology of the reaction, the immune response to the skin test in subjects with positive skin test will be evaluated by measuring serum antibody levels against bovine collagen.		60 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects 18 years of age or older, male or female.
Subjects who are healthy and have normal skin on the volar surface of the forearm.
Subjects willing and able to comply with the requirements of the study.
Subjects willing and able to comply with the follow-up requirements.
Subjects willing and able to give written and verbal informed consent.

Exclusion Criteria:

Subjects who are pregnant, nursing or intend to become pregnant.
Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
Subjects who were or are currently being treated with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids (including inhaled or insufflated) within the past 3 months.
Subjects who were or are currently being treated with any topical OTC drug or prescription therapy on their arms (below the elbow) within the past 3 months.
Subjects with a history indicative of abnormal immune function (e.g. auto- immune diseases, HIV, cancer, etc).
Subjects with known lidocaine hypersensitivity.
Subjects with known sensitivity to bovine collagen.
Subjects who have a history of dietary beef allergy, undergoing desensitization to beef products or planning to undergo desensitization within the study evaluation period.
Subjects with severe allergies manifested by a history of anaphylaxis.
Subject is currently enrolled in an investigational drug or device study.
Subject has received an investigational drug or an investigational device within 30 days prior to entering this study.
Subject has any skin pathology or condition that could interfere with the evaluation of the treatment areas.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided