Yulex Glove Prospective Study in Spina Bifida

Spina Bifida Clinical Trial

Official title:

Yulex Glove Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01133288
• Other study ID #: NA_00024249
• Status: Terminated
• Phase: N/A
• First received: May 26, 2010
• Last updated: November 21, 2011
• Start date: July 2009
• Est. completion date: July 2011

Study information

• Verified date: November 2011
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Latex Allergy
• Latex Hypersensitivity
• Spina Bifida
• Spinal Dysraphism

Intervention

Device:
• Yulex gloves
Study participants will be asked to wear Yulex gloves for routine bowel and bladder care (~30 minutes per day) over a 3 month period.

Locations

Country	Name	City	State
United States	Hugo W. Moser Research Institute at Kennedy Krieger Inc.	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitization to Yulex	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	Yes
Secondary	Immune Response to Yulex	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	Yes