Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04773587
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2021-02-24
Brief Title:
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Sponsor:
Arcutis Biotherapeutics Inc
Organization:
Arcutis Biotherapeutics Inc
Study Overview
Official Title:
A Phase 3 4-Week Parallel Group Double Blind Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 015 Administered QD in Subjects With Atopic Dermatitis
Status:
COMPLETED
Status Verified Date:
2024-09
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:
INTEGUMENT-I
Brief Summary:
This is a parallel group double blind vehicle-controlled study to assess the safety and efficacy of roflumilast ARQ-151 cream vs vehicle applied once daily qd for 4 weeks by participants with atopic dermatitis eczema
Detailed Description:
This is a parallel group double blind vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis
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