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

Dermatitis, Atopic Clinical Trial

— Dermatitis  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078294
• Other study ID #: FIS-DER-2021-01
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: José Juan Pereyra Rodríguez
• Phone: 955 01 20 00
• Email: josej.pereyra.sspa[@]juntadeandalucia.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital General de Granollers	Granollers	Barcelona
Spain	Hospital Universitario Puerta de Hierro	Majadahonda	Madrid
Spain	Hospital Universitario Puerta Real	Puerto Real	Cádiz
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Arnau de Vilanova	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Medication-related adverse effect rate.	Number of adverse effects.	Up to 30 weeks
Secondary	Evaluation of quality of life parameters.	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.	Up to 30 weeks