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

NCT00778089 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2019-09-27

No results posted yet for this 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

Conditions

Interventions

DEVICE

ArteFill® 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.

Sponsors & Collaborators

  • Suneva Medical, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-12-03
Completion
2008-12-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778089 on ClinicalTrials.gov