Ignite Creation Date:
2024-05-06 @ 2:06 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04211363
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2019-12-23
Brief Title:
Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Sponsor:
Arcutis Biotherapeutics Inc
Organization:
Arcutis Biotherapeutics Inc
Study Overview
Official Title:
A Phase 3 8-Week Parallel Group Double Blind Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 03 Administered QD in Subjects With Chronic Plaque Psoriasis
Status:
COMPLETED
Status Verified Date:
2022-12
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:
DERMIS-1
Brief Summary:
This is a double-blind parallel group vehicle-controlled study to assess the safety and efficacy of roflumilast ARQ-151 03 cream vs vehicle placebo cream for treatment of chronic plaque psoriasis CPP in adult participants with 2 to 20 body surface area BSA of CPP
Detailed Description:
None
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