HypersensitivityNCT00778089
Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
A study testing ArteFill® Skin Test in people with Hypersensitivity, run by Suneva Medical, Inc. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- ArteFill® Skin Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 498 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to 3 Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Education & Research Foundation, Inc.
Lynchburg, Virginia, 24501
About this study
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
Read the 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.
- Conditions
- Hypersensitivity
- Being tested
- ArteFill® Skin Test
- Keywords
- skin test, ArteFill, Skin test prior to administration of ArteFill® implant
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArteFill® Skin TestDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Single Arm | Other | All enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine. Receives: Device: ArteFill® Skin Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startJul 2008
- Primary completion3 Dec 2008
- Study completion3 Dec 2008
Why it stopped: Closed incomplete due to Artes Medical Closing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suneva Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David C Wilson, M.D., Principal investigator, The Education & Research Foundation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778089
- Sponsor's protocol ID
- D82-3001-07
- Status last verified
- Mar 2010
- First submitted
- 21 Oct 2008
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate the Immunogenicity of Bovine Collagen in ArteFill® by Skin Testing
- ClinicalTrials.gov ID
- NCT00778089
- Acronym / sponsor ID
- D82-3001-07
- Conditions
- Hypersensitivity
- Keywords
- skin test, ArteFill, Skin test prior to administration of ArteFill® implant
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed incomplete due to Artes Medical Closing
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Suneva Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- 3 Dec 2008 (actual)
- Study completion
- 3 Dec 2008 (actual)
- First posted
- 23 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Single Arm | Other | Device: ArteFill® Skin TestAll enrolled subjects will have a skin test composed of Bovine Collagen and Lidocaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArteFill® Skin TestSubjects 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. | Device | Open Label Single Arm |
Primary outcome
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events.
Time frame: 60 days
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Closed incomplete due to Artes Medical Closing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Wilson, M.D. principal investigator
The Education & Research Foundation, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArteFill® Skin Test in people with Hypersensitivity, run by Suneva Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Closed incomplete due to Artes Medical Closing). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be assessed by determination of a positive hypersensitivity reaction to the skin test and collection of adverse events. (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.