Yulex Glove Prospective Study in Spina Bifida

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01133288
• Collaborator: Johns Hopkins University (Other)
• Enrollment: 7
• Location: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spina Bifida; Latex Allergy	Device: Yulex gloves	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Yulex Glove Prospective Study
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Outcome Measures

Primary Outcome Measures

1. Sensitization to Yulex [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.

Secondary Outcome Measures

1. Immune Response to Yulex [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hugo W. Moser Research Institute at Kennedy Krieger Inc.	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Johns Hopkins University

Investigators

• Principal Investigator: Eric B Levey, M.D, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Charles Curry, Research assistant/co-investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• ClinicalTrials.gov Identifier: NCT01133288
• Other Study ID Numbers: NA_00024249
• First Posted: May 28, 2010
• Last Update Posted: Dec 23, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Spinal Dysraphism; Latex Hypersensitivity

Study Results

Participant Flow

Recruitment Details	Participants were recruited from July 2009 until May 2010. Only 7 participants were enrolled. None of the participants completed the study. Funding was never received from the study sponsor, so the study was terminated.
Pre-assignment Detail	Of 7 individuals who enrolled in the study, 2 passed screening and were found to be latex allergic. Funding was never received from the study sponsor and the study was terminated. The 3 month trial of Yulex gloves was not started with any of the participants, so no intervention data is available.

Arm/Group Title	Yulex Glove
Arm/Group Description	Yulex Glove Treatment
Period Title: Eligibility Assessment
STARTED	7
COMPLETED	2
NOT COMPLETED	5
Period Title: Eligibility Assessment
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Yulex Glove
Arm/Group Description	Yulex Glove Treatment
Overall Participants	7
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.3 (6.57)
Sex: Female, Male (Count of Participants)
Female	3 42.9%
Male	4 57.1%
Region of Enrollment (participants) [Number]
United States	7 100%

Outcome Measures

1. Primary Outcome

Title	Sensitization to Yulex
Description	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.
Time Frame	Approximately 3 months

Outcome Measure Data

Analysis Population Description

No participants were exposed to Yulex because the study was terminated.

Arm/Group Title	Yulex Glove
Arm/Group Description	Yulex Glove Treatment
Measure Participants	0

2. Secondary Outcome

Title	Immune Response to Yulex
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Yulex Glove
Arm/Group Description	Yulex Glove Treatment
Measure Participants	0

Adverse Events

Time Frame	Adverse events were to be assessed over a three month study period. Event data was only assessed on visit one, as none of the participants progressed to visit 2 and no participants received the yulex glove intervention.
Arm/Group Title	Yulex Glove
Arm/Group Description	Yulex Glove Treatment
All Cause Mortality
	Yulex Glove
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Yulex Glove
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Yulex Glove
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

The study was not completed because funding was never received. The two (2/7)enrolled participants who met screening eligibility criteria were terminated early without receiving the yulex glove intervention.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.