Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-27 @ 11:32 PM
Study NCT ID:
NCT05078294
Status:
UNKNOWN
Last Update Posted:
2021-11-17
First Post:
2021-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Study Overview
Official Title:
Results in Real Clinical Practice of Treatment With Patients With Moderate-severe Atopic Dermatitis
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
Dermatitis
Brief Summary:
The purpose of this study is to determine the efficacy results in terms of percentage improvement of the Eczema Area and Severity Index (EASI) as well as on the scale Patient Global Assessment (PGA) throughout the follow-up of patients undergoing subjected to systemic and/or biological treatments in conditions of usual clinical practice. Likewise, collect safety data, recording adverse events related to medication.
Detailed Description:
This is an observacional follow-up study, open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center study in adult participants with moderate to severe atopic dermatitis. A registration can also be made retrospective data from the patient's medical history.
Participants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).
A series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD).
Participants will be treated with one of this therapy (phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib or tralokilumab).
A series of variables will be measured (basal surface area affected (BSA), Eczema Area and Severity Index (EASI), numbers of shoots, analytical determinations and current treatment and adverse effects occurred) in order to observe the changes in the improvement of the disease. Questionnaires will also be carried out to analyze whether the drug acts favorably in improving the disease. Questionnaires like Dermatology Life Quality Index (DLQI), Patient Global Assesment (PGA) and Patient Oriented SCOring Atopic Dermatitis (PO-SCORAD).
Study Oversight
Has Oversight DMC:
False
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?: