Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549870
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2020-09-08
Brief Title:
Efficacy of Roflumilast in the Treatment of Psoriasis
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
Efficacy of Roflumilast in the Treatment of Psoriasis - a Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-06
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:
PSORRO
Brief Summary:
Roflumilast Daxas a selective long-acting inhibitor of the enzyme phosphodiesterase-4 PDE4 is used for severe chronic obstructive pulmonary disease Recent research suggest roflumilast is effective in treating psoriasis The aim of this investigator-initiated trial is to study the efficacy of oral roflumilast in patients with plaque psoriasis This has not previously been done
Detailed Description:
Aim To investigate the efficacy of roflumilast in the treatment of psoriasis
Design Multicentre double-blinded randomised placebo-controlled clinical trial
Participants Patients 18 years with plaque psoriasis
Method Twelve weeks treatment with either roflumilast or placebo tablets Both groups continue for an additional 12 weeks open-label treatment
Primary endpoint Proportion of patients achieving at least 75 reduction from baseline psoriasis area and severity index PASI75 at week 12
Design Multicentre double-blinded randomised placebo-controlled clinical trial
Participants Patients 18 years with plaque psoriasis
Method Twelve weeks treatment with either roflumilast or placebo tablets Both groups continue for an additional 12 weeks open-label treatment
Primary endpoint Proportion of patients achieving at least 75 reduction from baseline psoriasis area and severity index PASI75 at week 12
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