Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366932
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-03-07
Brief Title:
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Organization:
Instituto de Investigación Hospital Universitario La Paz
Study Overview
Official Title:
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Multiomic Predictive Models of Treatment Response DermAtOmics-II
Status:
RECRUITING
Status Verified Date:
2024-03
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 low-intervention phase IV trial The main objective is to optimize the treatment of patients with moderate-severe atopic dermatitis that require systemic treatment after failure intolerance or contraindication to cyclosporine
Detailed Description:
Primary outcome is the percentage of patients with primary non-response to second-line treatment Defined as fail to achieve EASI-75 a 75 improvement in EASI score at week 16 of follow-up A 12-month recruitment period is planned and about 150 patients with moderate-severe atopic dermatitis will be recruited The study is divided into two cohorts All patients diagnosed with moderate to severe atopic dermatitis who are going to receive second-line systemic treatment at the Dermatology Department of La Paz University Hospital are selected in cohort 1 Patients will receive the starting dose used in routine clinical practice All patients diagnosed with moderate to severe atopic dermatitis who are receiving second-line systemic treatment at the Dermatology Department of La Paz University Hospital will be selected in cohort 2
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