Clinical trial NCT05078294: Results in Real Clinical Practice of Treatment of Moderate-severe Atopic Dermatitis
Official title: Results in Real Clinical Practice of Treatment With Patients With Moderate-severe Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dermatitis, Atopic
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants who showed a change in disease severity.
timeFrame: Up to 30 weeks
Secondary outcomes:
measure: Medication-related adverse effect rate.
timeFrame: Up to 30 weeks
measure: Evaluation of quality of life parameters.
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Hospital General de Granollers
state: Barcelona
city: Puerto Real
country: Spain
facility: Hospital Universitario Puerta Real
state: Cádiz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro
state: Madrid
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital Sant Pau
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: José Juan Pereyra Rodríguez
role: PRINCIPAL_INVESTIGATOR
References: