Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis

Recruiting

• Conditions: Dermatitis, Atopic

• Registration Number: NCT05078294
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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).

Study Timeline

• Study Start: 2021-08-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-30
• Study First Posted: 2021-10-14
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17
• Primary Completion: 2024-06-01
• Study Completion: 2024-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who showed a change in disease severity.	Up to 30 weeks	Percentage improvement in Eczema Area and Severity Index (EASI) throughout the follow-up of patients undergoing systemic treatments and/or biological.

Secondary Outcome Measures

Name	Time	Method
Medication-related adverse effect rate.	Up to 30 weeks	Number of adverse effects.
Evaluation of quality of life parameters.	Up to 30 weeks	Completion of the self-administered dermatology quality of life index questionnaire, which measures the quality of life of the patient.; Numerical variable (range 0-30) obtained from a self-administered questionnaire already validated in Spanish, which measures the quality of life of surveyed, consisting of 10 questions.

Trial Locations

Locations (7)

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Barcelona, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Puerta Real; 🇪🇸 Puerto Real, Cádiz, Spain