Trial Outcomes & Findings for Yulex Glove Prospective Study in Spina Bifida (NCT NCT01133288)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Approximately 3 months

Results posted on

2011-12-23

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Yulex Glove Yulex Glove Treatment
Eligibility Assessment STARTED	7
Eligibility Assessment COMPLETED	2
Eligibility Assessment NOT COMPLETED	5
Intervention Allocation STARTED	2
Intervention Allocation COMPLETED	0
Intervention Allocation NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Yulex Glove Yulex Glove Treatment
Eligibility Assessment met exclusion criteria	5
Intervention Allocation study terminated	2

Baseline Characteristics

Yulex Glove Prospective Study in Spina Bifida

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yulex Glove n=7 Participants Yulex Glove Treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	31.3 years STANDARD_DEVIATION 6.57 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 3 months

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Yulex Glove

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Levey, M.D.

Kennedy Krieger Institute

Phone: 443-923-9148

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place