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

November 15, 2021 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario de Alicante
        • Contact:
          • Juan Francisco Silvestre Salvador
          • Phone Number: 965 93 30 00
        • Principal Investigator:
          • Juan Francisco Silvestre Salvador
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Sant Pau
        • Contact:
          • Esther Serra-Baldrich
          • Phone Number: 93 291 90 00
        • Principal Investigator:
          • Esther Serra-Baldrich
        • Sub-Investigator:
          • Victor Flores
        • Sub-Investigator:
          • Guillermo Sánchez
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • José Juan Pereyra Rodríguez
      • Valencia, Spain, 46015
        • Recruiting
        • Hospital Arnau de Vilanova
        • Contact:
          • Francisco Javier Miquel Miquel
          • Phone Number: 961 97 60 00
        • Principal Investigator:
          • Francisco Javier Miquel Miquel
    • Barcelona
      • Granollers, Barcelona, Spain, 08402
        • Recruiting
        • Hospital General de Granollers
        • Contact:
          • Antonio Guilabert Vidal
          • Phone Number: 938 42 50 00
        • Principal Investigator:
          • Antonio Guilabert Vidal
    • Cádiz
      • Puerto Real, Cádiz, Spain, 11510
        • Recruiting
        • Hospital Universitario Puerta Real
        • Contact:
          • José Carlos Armario Hita
          • Phone Number: 956 00 50 00
        • Principal Investigator:
          • José Carlos Armario Hita
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Contact:
          • Marta Elosua González
          • Phone Number: 911 91 60 00
        • Sub-Investigator:
          • Ángel Rosell Díaz
        • Sub-Investigator:
          • Gaston Roustan Gullón

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population would be patients older than 18 years who suffer from the disease and are being treated with a systemic therapy.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who showed a change in disease severity.
Time Frame: 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.
Up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication-related adverse effect rate.
Time Frame: Up to 30 weeks
Number of adverse effects.
Up to 30 weeks
Evaluation of quality of life parameters.
Time Frame: 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.
Up to 30 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

  • Principal Investigator: José Juan Pereyra Rodríguez, Hospitales Universitarios Virgen del Rocío

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

September 9, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS-DER-2021-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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