Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04882319
Status:
COMPLETED
Last Update Posted:
2022-08-23
First Post:
2021-05-03
Brief Title:
Irritation and Sensitization Study of HP-5000 Topical System
Sponsor:
Noven Pharmaceuticals Inc
Organization:
Noven Therapeutics
Study Overview
Official Title:
An Evaluator-blinded Randomized Within-subject Repeat Insult Study to Evaluate Potential Skin Irritation and Sensitization of HP-5000 Diclofenac Sodium Topical System in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2022-08
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:
This study will assess skin irritation and sensitization for HP-5000 patch in healthy subjects
Detailed Description:
This is an evaluator-blinded randomized phase 1 study evaluating skin irritation and sensitization of HP-5000 topical system in comparison to control patches The study will consist of a 4-week Screening Phase and a Treatment Phase The Treatment Phase will consist of the following periods an Induction Period a Rest Period followed by a Challenge Period and if needed a Re-Challenge Period
Study Oversight
Has Oversight DMC:
None
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?:
None