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

NCT ID: NCT05078294

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-11-01

Brief Summary

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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

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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).

Conditions

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Dermatitis, Atopic

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Juan Pereyra Rodríguez

Role: PRINCIPAL_INVESTIGATOR

Hospitales Universitarios Virgen del Rocío

Locations

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Hospital General de Granollers

Granollers, Barcelona, Spain

Site Status RECRUITING

Hospital Universitario Puerta Real

Puerto Real, Cádiz, Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status RECRUITING

Hospital General Universitario de Alicante

Alicante, , Spain

Site Status RECRUITING

Hospital Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

Hospital Arnau de Vilanova

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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José Juan Pereyra Rodríguez

Role: CONTACT

Phone: 955 01 20 00

Email: [email protected]

Carlos García Pérez

Role: CONTACT

Phone: 955 04 31 27

Email: [email protected]

Facility Contacts

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Antonio Guilabert Vidal

Role: primary

José Carlos Armario Hita

Role: primary

Marta Elosua González

Role: primary

Juan Francisco Silvestre Salvador

Role: primary

Esther Serra-Baldrich

Role: primary

José Juan Pereyra Rodríguez

Role: primary

Francisco Javier Miquel Miquel

Role: primary

Other Identifiers

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FIS-DER-2021-01

Identifier Type: -

Identifier Source: org_study_id