Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624867
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2020-10-22
Brief Title:
Study Will Assess Skin Irritation and Sensitization for HP-1050 Patch
Sponsor:
Noven Pharmaceuticals Inc
Organization:
Noven Therapeutics
Study Overview
Official Title:
A Phase I Study to Assess Skin Irritation and Sensitization of HP-1050 Transdermal System Compared to XULANE in Healthy Adult Females
Status:
UNKNOWN
Status Verified Date:
2021-08
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:
A randomized evaluator-blinded study to assess skin irritation and skin sensitization of HP-1050 transdermal system HP-1050 in comparison to XULANE patch in healthy female volunteers
Detailed Description:
This is a dual-center evaluator-blinded randomized phase 1 study evaluating skin irritation and skin sensitization of HP-1050 transdermal system in comparison to XULANE patch in healthy female volunteers 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