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

Primary Purpose

Hypersensitivity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ArteFill® Skin Test
Sponsored by
Suneva Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypersensitivity focused on measuring skin test, ArteFill, Skin test prior to administration of ArteFill® implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Education & Research Foundation, Inc.

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Label Single Arm

Arm Description

All enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine.

Outcomes

Primary Outcome Measures

Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.

Secondary Outcome Measures

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.

Full Information

First Posted
October 21, 2008
Last Updated
September 25, 2019
Sponsor
Suneva Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00778089
Brief Title
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
Official Title
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Terminated
Why Stopped
Closed incomplete due to Artes Medical Closing
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 3, 2008 (Actual)
Study Completion Date
December 3, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suneva Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersensitivity
Keywords
skin test, ArteFill, Skin test prior to administration of ArteFill® implant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label Single Arm
Arm Type
Other
Arm Description
All enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine.
Intervention Type
Device
Intervention Name(s)
ArteFill® Skin Test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Wilson, M.D.
Organizational Affiliation
The Education & Research Foundation, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Education & Research Foundation, Inc.
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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