Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05259722
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2022-02-18
Brief Title:
A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mgg Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
Sponsor:
LEO Pharma
Organization:
LEO Pharma
Study Overview
Official Title:
A 24 Week Randomised Assessor Blinded Active-controlled Parallel Group Phase 3 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mgg Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema
Status:
COMPLETED
Status Verified Date:
2024-04
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 is a 24-week study in adult participants with severe chronic hand eczema CHE and with a documented inadequate response to treatment with topical corticosteroids TCS or for whom TCS are documented to be otherwise medically inadvisable Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mgg twice-daily or oral administration of alitretinoin capsules 30 mg with an option to reduce to 10 mg during trial conduct once-daily The participants will visit the clinic regularly to have the study doctor assess their CHE and to answer questions about itch pain CHE symptoms and quality of life
The purpose of this trial is to compare the efficacy health-related quality of life and safety of delgocitinib cream and alitretinoin capsules
The purpose of this trial is to compare the efficacy health-related quality of life and safety of delgocitinib cream and alitretinoin capsules
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-003543-16 | EUDRACT_NUMBER | None | None |