- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133288
Yulex Glove Prospective Study in Spina Bifida
November 21, 2011 updated by: Charles Curry, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Yulex Glove Prospective Study
This study is to evaluate the safety of Yulex gloves when used by individuals who have documented allergy to natural rubber latex from Hevea brasiliensis.
Yulex is a latex from a different plant (Guayule) and in previous studies shows no cross-reactivity to Hevea latex and has not been allergenic in workers exposed to Yulex.
The FDA has approved Yulex gloves for use in the general population and has recognized and labeled these gloves as Hevea Latex-free.
The labeling still includes a precaution that Yulex gloves may pose a risk for development of allergy because Yulex does contain a small amount of Guayule protein.
Yulex Corporation has proposed doing further studies to demonstrate safety and lack of allergenicity in a population that is prone to latex allergy.
In the proposed pilot study, the investigators goal is to complete the protocol on 10 adults with spina bifida who are allergic to natural rubber latex who will wear Yulex gloves as part of their regular bladder and bowel care for approximately 30 minutes daily over a 3 month period.
The investigators anticipate that the investigators will need to recruit and enroll up to 50 study participants to achieve a final sample of 10 adults with complete study data.
Individuals with a history of anaphylaxis will be excluded from the study.
The study participants will be tested for Yulex allergy by Glove Puncture Test as well as serology at the beginning and end of the study.
The FDA Devices group has reviewed the study design and agreed that this is a suitable first pilot study.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
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
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Hugo W. Moser Research Institute at Kennedy Krieger 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 to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Individuals with spina bifida between the ages of 18 and 60 who exhibit positive serology to latex (Hevea Brasiliensis).
Exclusion Criteria:
- Possible exclusion criteria include age under 18, does not have spina bifida, or does not exhibit positive serology to latex (Hevea Brasiliensis).
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
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitization to Yulex
Time Frame: Approximately 3 months
|
The primary study outcome will be an assessment for sensitization to Yulex as determined by serological assay for Guayule-specific IgE antibodies.
The development of a detectable IgE immune response will be considered a positive study.
|
Approximately 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immune Response to Yulex
Time Frame: 3 months
|
A secondary study outcome is the development of an immune response to Yulex using a human IgG anti-Guayule immunoassay.
The development of a detectable IgG immune response will be considered a positive study.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Eric B Levey, M.D, Hugo W. Moser Research Institute at Kennedy Krieger, 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, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
May 26, 2010
First Submitted That Met QC Criteria
May 27, 2010
First Posted (Estimate)
May 28, 2010
Study Record Updates
Last Update Posted (Estimate)
December 23, 2011
Last Update Submitted That Met QC Criteria
November 21, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00024249
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.
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