Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
Study NCT ID:
NCT04312750
Status:
COMPLETED
Last Update Posted:
2020-03-18
First Post:
2020-03-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adhesion of Lidocaine Topical System 1.8%
Sponsor:
Scilex Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
An Open Label, Single-treatment, Single-period, Single-application, Adhesion Performance Study of Lidocaine Patch 36 mg/Patch (1.8%) in Healthy, Adult, Human Subjects.
Status:
COMPLETED
Status Verified Date:
2020-03
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:
The objective of this study is to evaluate the adhesion performance of ZTlido (lidocaine topical system) 1.8% in normal, healthy volunteers.
Detailed Description:
In this open-label, single-treatment, single-period, single-application adhesion performance study, 54 healthy, adult male and female subjects are treated with one lidocaine topical system to their back for 12 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed after the topical system is removed.
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?: