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

NCT00778089 | Terminated FDA Device

• 1 other identifier: D82-3001-07
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

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

Conditions

Hypersensitivity

Keywords

skin test; ArteFill; Skin test prior to administration of ArteFill® implant

Outcome Measures

Primary Outcomes (1)

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

  60 days

Secondary Outcomes (1)

• 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

Study Arms (1)

Open Label Single Arm

OTHER

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

Device: ArteFill® Skin Test

Interventions

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.

Open Label Single Arm

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suneva Medical, Inc.: lead

Study Sites (1)

The Education & Research Foundation, Inc.

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• David C Wilson, M.D.

  The Education & Research Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 23, 2008
• Study Start: July 1, 2008
• Primary Completion: December 3, 2008
• Study Completion: December 3, 2008
• Last Updated: September 27, 2019

Record last verified: 2010-03

Locations

US (1)