Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-01-07 @ 12:09 PM
Study NCT ID:
NCT04500834
Status:
UNKNOWN
Last Update Posted:
2023-02-13
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metal Panel Allergen Patch Test Study
Sponsor:
Allerderm
Organization:
Study Overview
Official Title:
Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study
Status:
UNKNOWN
Status Verified Date:
2023-02
Last Known Status:
RECRUITING
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:
Metal allergen patch test study.
Detailed Description:
A single application of an investigational patch test panel containing 11 hydrogel metal allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will be applied to the upper back of human subjects to test diagnostic efficacy and safety. Patch test panels will be removed after being worn for approximately 48 hours. Study will require 6 visits over the course of 21 days; patch application, patch removal and 4 patch test site evaluation visits at days 4, 7, 14 and 21.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: