Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis
Dermatitis
1 other identifier
observational
300
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
September 9, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedNovember 17, 2021
September 1, 2021
2.8 years
September 9, 2021
November 15, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants who showed a change in disease severity.
Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological.
Up to 30 weeks
Secondary Outcomes (2)
Medication-related adverse effect rate.
Up to 30 weeks
Evaluation of quality of life parameters.
Up to 30 weeks
Study Arms (1)
Cases
Patients treated as monotherapy with phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib, or tralokilumab for the treatment of moderate to severe atopic dermatitis.
Eligibility Criteria
The study population would be patients older than 18 years who suffer from the disease and are being treated with a systemic therapy.
You may qualify if:
- Over 18 years.
- Patients treated with any systemic therapy (other than topical therapy) according to criteria clinical and routine clinical practice. Therefore, the treatments included will be: phototherapy, cyclosporine, methotrexate, azathioprine, mycophenolate, dupilumab, baricitinib, upadacitinib and tralokilumab.
- Patients who grant informed consent.
You may not qualify if:
- Patients who do not have the necessary comprehension capacity to understand and sign the informed consent.
- Patients who, according to routine clinical practice, require only topical treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Hospital General de Granollers
Granollers, Barcelona, 08402, Spain
Hospital Universitario Puerta Real
Puerto Real, Cádiz, 11510, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
Hospital General Universitario de Alicante
Alicante, 03010, Spain
Hospital Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Virgen del Rocío
Seville, 41013, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
José Juan Pereyra Rodríguez
Hospitales Universitarios Virgen del Rocío
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2021
First Posted
October 14, 2021
Study Start
August 1, 2021
Primary Completion
June 1, 2024
Study Completion
November 1, 2024
Last Updated
November 17, 2021
Record last verified: 2021-09