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

Stopped early · Not applicable

Conditions studied: Hypersensitivity

In brief

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

Key facts

Study ID

NCT00778089

Run by

Suneva Medical, Inc.

People needed

498

Starts

2008-07-01

Expected to finish

2008-12-03

Last updated by the study team

2019-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• The Education & Research Foundation, Inc. — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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