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Evaluation of Allergenicity of Hypoallergenic Peanut Product in Peanut Allergic Subjects

NCT01489514 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 22

Last updated 2015-05-27

No results posted yet for this study

Summary

This is a proof of concept study to determine the safety and allergenicity of hypoallergenic peanut product extract as compared to standard peanut extract in an adult population with known peanut allergy. This will be assessed by epicutaneous skin prick testing. The hypothesis is that subjects with previously diagnosed peanut allergy will have less epicutaneous reactions to the hypoallergenic peanut product extract.

Conditions

Interventions

OTHER

Epicutaneous skin prick testing

Epicutaneous skin prick testing will be performed utilizing the following extracts: 1. Histamine control purchased from Greer. 2. Saline control purchased from Greer. 3. Standard Peanut Extract purchased from Greer. 4. Sterile extract prepared from Trypsin and Chymotrypsin treated peanuts. This is prepared by North Carolina A \& T. 5. Sterile extract prepared from roasted \& blanched but untreated peanuts. This is prepared by North Carolina A \& T. 6. Sterile extract prepared from peanuts (no blanching, no enzyme). This is prepared by North Carolina A \& T. This is not classified as a drug and is 7. Sterile extract containing peanuts treated with 0.2% inactivated a-chymotrypsin and trypsin as an enzyme negative control. 8. Sterile extracts containing peanuts that have been treated with alcalase

Sponsors & Collaborators

  • North Carolina Agriculture & Technical State University

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Michelle Hernandez, MD · University of North Carolina

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489514 on ClinicalTrials.gov