Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05919082
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-06-16
Brief Title:
A Study to Investigate Efficacy and Safety With LEO 90100 Compared With Daivobet Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
Official Title:
A Phase 3 Randomised Investigator-blind Active-controlled Parallel Group Multicentre Trial Comparing the Efficacy and Safety of 4-weeks Treatment With LEO 90100 and Daivobet Ointment in Adult Chinese Subjects With Stable Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2024-07
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 is conducted to assess the efficacy and safety of LEO 90100 when used on the body for the treatment of stable plaque psoriasis in native adult Chinese subjects compared to Daivobet ointment
Detailed Description:
This study is phase 3 randomised prospective investigator-blinded active-controlled parallel group multicentre trial to evaluate the efficacy and safety of 4 weeks treatment with LEO 90100 compared with Daivobet ointment Eligible participants will be randomised in a 11 ratio to either LEO 90100 or Daivobet ointment treatment
The trial will last for 6 weeks to 10 weeks for each participant which includes wash out period and treatment period of up to 4 weeks and a safety follow up period of 2 weeks
The trial will last for 6 weeks to 10 weeks for each participant which includes wash out period and treatment period of up to 4 weeks and a safety follow up period of 2 weeks
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1285-7764 | OTHER | World Health Organization WHO | None |