Latex Allergy, Spina Bifida
Conditions
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.
Interventions
DEVICEYulex 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.
Sponsors
Johns Hopkins University
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Yulex Glove Yulex Glove Treatment | 7 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Eligibility Assessment | met exclusion criteria | 5 |
| Intervention Allocation | study terminated | 2 |
Baseline characteristics
| Characteristic | Yulex Glove |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age Continuous | 31.3 years STANDARD_DEVIATION 6.57 |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Approximately 3 months
Population: No participants were exposed to Yulex because the study was terminated.
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.
Time frame: 3 months