Status:
TERMINATED
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
Lead Sponsor:
Suneva Medical, Inc.
Conditions:
Hypersensitivity
Eligibility:
All Genders
18+ years
Phase:
NA
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 ev...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2008
Estimated Enrollment :
498 Patients enrolled
Trial Details
Trial ID
NCT00778089
Start Date
July 1 2008
End Date
December 3 2008
Last Update
September 27 2019
Active Locations (1)
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1
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States, 24501