Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-02 @ 10:11 AM
Study NCT ID:
NCT02787356
Status:
WITHDRAWN
Last Update Posted:
2017-10-09
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
Sponsor:
SRI International
Organization:
Study Overview
Official Title:
Standard TDS Irritation Study: Trained Skin Grader vs. Digital Imaging
Status:
WITHDRAWN
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Project was not funded by FDA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TDS_TSG_DI
Brief Summary:
The purpose of this study is to (1) collect trained observer scores and digital images of skin irritated by generic and RLD Lidocaine 5% delivered via TDS, and (2) assess performance of an automated system for predicting scores directly from the digital images
Detailed Description:
Subjects will be screened prior to dosing to ensure subjects meet all inclusion exclusion criteria. The test materials will be tested simultaneously. Skin sites on the paraspinal region will be utilized for application. The test sites will be randomized among the individual subjects according to their assigned identification number. All patches will be applied and removed by the laboratory staff.
Due to safety concerns, it is not recommended to simultaneously apply two whole, active, Lidocaine Patch 5% patches on the same subject during the 21-day period. The optimum design of this study will depend on the design of the test product patch. Since the RLD has a matrix design that can be safely cut, one-fourth of the patch can be used for these studies. If the test product patch also has a design that can be cut to a smaller size, it should also be cut in one-fourth and one-fourth of the test product patch applied simultaneously with one-fourth of a RLD patch (to separate skin sites).
Each test article will be applied to sites on the skin for a contact period of approximately 24 hours (+/-1 hr.), with the exception of the weekend (72 hours, +/- 1 hr.). There will be no visits during the weekend.
Evaluations will be made after removal of every patch by a single trained grader along with a single digital imaging instrument. Re-applications will be made to the same test sites unless reactions become so strong (combination of a number and letter grade of 3) as to make this unadvisable, at which point patch application will be discontinued for that test article.
Due to safety concerns, it is not recommended to simultaneously apply two whole, active, Lidocaine Patch 5% patches on the same subject during the 21-day period. The optimum design of this study will depend on the design of the test product patch. Since the RLD has a matrix design that can be safely cut, one-fourth of the patch can be used for these studies. If the test product patch also has a design that can be cut to a smaller size, it should also be cut in one-fourth and one-fourth of the test product patch applied simultaneously with one-fourth of a RLD patch (to separate skin sites).
Each test article will be applied to sites on the skin for a contact period of approximately 24 hours (+/-1 hr.), with the exception of the weekend (72 hours, +/- 1 hr.). There will be no visits during the weekend.
Evaluations will be made after removal of every patch by a single trained grader along with a single digital imaging instrument. Re-applications will be made to the same test sites unless reactions become so strong (combination of a number and letter grade of 3) as to make this unadvisable, at which point patch application will be discontinued for that test article.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: