- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00778089
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
September 25, 2019 updated by: Suneva Medical, Inc.
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
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
498
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Lynchburg, Virginia, United States, 24501
- The Education & Research Foundation, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Open Label Single Arm
All enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.
Time Frame: 60 days
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: 60 days
|
60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David C Wilson, M.D., The Education & Research Foundation, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
December 3, 2008
Study Completion (Actual)
December 3, 2008
Study Registration Dates
First Submitted
October 21, 2008
First Submitted That Met QC Criteria
October 22, 2008
First Posted (Estimate)
October 23, 2008
Study Record Updates
Last Update Posted (Actual)
September 27, 2019
Last Update Submitted That Met QC Criteria
September 25, 2019
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D82-3001-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypersensitivity
-
National Institute of Allergy and Infectious Diseases...Consortium of Food Allergy ResearchCompletedMilk Hypersensitivity | Egg Hypersensitivity | Food Hypersensitivity | Peanut HypersensitivityUnited States
-
Ospedale Buon Consiglio FatebenefratelliCompleted- Egg HypersensitivityItaly
-
National Institute of Allergy and Infectious Diseases...Consortium of Food Allergy ResearchCompletedHypersensitivity | Food Hypersensitivity | Peanut Hypersensitivity | Immediate HypersensitivityUnited States
-
Johns Hopkins UniversityCompletedFood Hypersensitivity | Peanut Hypersensitivity | Immediate HypersensitivityUnited States
-
Allertein Therapeutics, LLCConsortium of Food Allergy ResearchCompletedHypersensitivity | Food Hypersensitivity | Peanut Hypersensitivity | Immediate HypersensitivityUnited States
-
IRCCS Burlo GarofoloCompleted
-
Alton MeltonThe Cleveland ClinicActive, not recruiting
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)Completed
-
National Institute of Allergy and Infectious Diseases...Consortium of Food Allergy ResearchCompletedHypersensitivity | Food Hypersensitivity | Hypersensitivity, Immediate | Peanut HypersensitivityUnited States
-
University of North Carolina, Chapel HillGenentech, Inc.CompletedPeanut HypersensitivityUnited States
Clinical Trials on ArteFill® Skin Test
-
AllerdermCompletedContact DermatitisDenmark, United States
-
Nielsen BioSciences, Inc.CompletedWarts | Human Papilloma VirusUnited States
-
AllerdermCompletedContact DermatitisUnited States, Denmark
-
HippocreatesCompletedAllergy Pollen | Allergy to House DustBelgium
-
Meir Medical CenterCompleted
-
University of ZurichCompleted
-
University of ZurichRecruitingHypersensitivity, FoodSwitzerland
-
Hadassah Medical OrganizationUnknownCoronary Stent RestenosisIsrael
-
Prof. Dr. Claus Bachert BVBAUnknownAllergic Rhinitis | Allergic Conjunctivitis | Food Allergy | Allergic Asthma