Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT01343420
Status:
COMPLETED
Last Update Posted:
2021-01-19
First Post:
2011-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dog Hair Extract Study
Sponsor:
National Jewish Health
Organization:
Study Overview
Official Title:
Dog Hair Evaluation Potency by Prick Skin Testing
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: