CClinicalTrials.gg
Sign In
TerminatedNCT00778089Updated Sep 27, 2019

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

An interventional study of ArteFill® Skin Test in Hypersensitivity, sponsored by Suneva Medical, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-27.

Sponsored by Suneva Medical, Inc. · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Closed incomplete due to Artes Medical Closing
Phase
Not applicable
Study type
Interventional
Enrollment
498
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hypersensitivity

Browse trials for

Keywords

  • skin test
  • ArteFill
  • Skin test prior to administration of ArteFill® implant
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
498 participants (actual)

Study arms

  • Other
    Open Label Single Arm

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

    Device: ArteFill® Skin Test

Interventions

  • DeviceArteFill® Skin Test

    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.

05

What researchers measure

Primary outcomes

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

    Time frame: 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.

    Time frame: 60 days

06

Study locations

1 site
  • The Education & Research Foundation, Inc.
    Lynchburg, Virginia 24501, United States
07

Registry details

Key details

Study ID
NCT00778089
Lead sponsor
Suneva Medical, Inc.
Responsible party
Sponsor
First posted
Oct 23, 2008
Start date
Jul 2008
Primary completion
Dec 3, 2008
Completion
Dec 3, 2008
Last update
Sep 27, 2019

Study contacts

David C Wilson, M.D.
principal investigator · The Education & Research Foundation, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypersensitivity→

Other studies from this sponsor

Suneva Medical, Inc.

Start the discussion