Ignite Creation Date:
2024-05-06 @ 3:12 AM
Last Modification Date:
2024-10-26 @ 11:29 AM
Study NCT ID:
NCT02221726
Status:
COMPLETED
Last Update Posted:
2014-09-15
First Post:
2014-08-19
Brief Title:
Study to Assess Adhesion Quality and Wear of Placebo JNJ-35685-AAA-G-023 Transdermal System in Healthy Adults
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
Evaluation of Scoring Methods to Assess Adhesion Quality and Wear of the Placebo JNJ-35685-AAA-G-023 55 cm2 and 44 cm2 Transdermal Systems
Status:
COMPLETED
Status Verified Date:
2014-09
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 purpose of this study is to assess 3 different scoring systems to evaluate the adhesive quality of placebo an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial JNJ-35685-AAA-G-023-G transdermal through the skin systems during a single system 72-hour application replicated 3 times of 2 patch sizes 55 centimeter2 cm2 and 44 cm2
Detailed Description:
This study will assess 3 different scoring systems to evaluate the adhesive quality of placebo patch an inactive patch that contains no active drug JNJ-35685-AAA-G-023-G transdermal through the skin system In this study this patch is NOT being compared to a patch with a drug and is NOT being used to test if the patch with the drug has a real effect in a clinical trial The study consists 3 parts Screening 21 days before study commences on Day 1 an adhesion assessment period 4 days and an end of Study EOS assessment recorded at 24 hours - 4 hours following patch removal Total study duration per participant will be 26 days including Screening JNJ-35685-AAA-G-023 small 55 cm2 and large 44 cm2 patches will be applied on to left or right side of the paraspinal region based on randomization schedule Adhesion assessments will be performed at patch application hour 0 Baseline and during the time interval of 8 to 10 hours 24 48 and 72 hours following patch application Adhesion quality will be assessed by visual grading United States Food and Drug Administration FDA scale digital image analysis and visual grading grid system Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FENPAI1024 | OTHER | Janssen Research Development LLC | None |