Dog Hair Extract Study
Liquid allergen extracts contain proteins, such as (but not limited to) tree, weed, cat, cockroach, and nuts, and are used to identify allergies by observing the body's reaction to the introduction of extract underneath the skin. There are a few dog allergen extracts commercially available in the US for allergy testing; however, none of these products are standardized, meaning they are not required to be the same strength. Because some extracts are not as potent (strong) as others, it's possible that some patients' allergies are misdiagnosed. Typically, the most potent (strong), but safe extract should be used so that allergic patients are correctly diagnosed.
The purpose of this study is to compare the safety and potency of an investigational (not approved for use by the United States Food and Drug Administration [FDA]) dog allergen extract with two commercially available dog extracts, which are of differing potencies.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
|Official Title:||Dog Hair Evaluation Potency by Prick Skin Testing|
- End-point dilution giving a positive prick skin test in dog allergic subjects. [ Time Frame: Study Completion ] [ Designated as safety issue: No ]The concentration of each allergen extract which produced a 5 mm wheal for each subject will be calculated. From this, the relative potency of each extract will be calculated.
|Study Start Date:||November 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Dog Hair Extract, ALK-Abelló, Inc.||
Biological: Dog Hair Extract, ALK-Abelló, Inc.
ALK-Abelló dog epithelial 1:10w/v glycerin
This study is designed to assess the potency of a modified dog hair and dander extract in comparison with the two commercially available dog hair and dander extracts. This is a pilot study to estimate a target strength of dog extract in order to proceed to further studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343420
|United States, Colorado|
|National Jewish Health|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||Harold Nelson, M.D.||National Jewish Health|