Actively Recruiting

All Genders
ID05674695

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Led by Fundación Academia Española de Dermatología · Updated on 2023-01-06

2500

Participants Needed

9

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of systemic immuno-modulatory therapies for children and adults with atopic eczema in Spain. This study, organized by the Spanish Academy of Dermatology and Venereology, aims to understand both short- and long-term effects of these treatments, including phototherapy, on patients' health and quality of life. The study also seeks to assess topical therapies, methods of care such as patient training, and related health conditions associated with atopic dermatitis. Participants in this observational study receive systemic drugs used in everyday clinical practice for atopic eczema, such as ciclosporin and potentially other immuno-modulatory agents. The study does not assign treatments but records usage and outcomes as part of routine care. There is no placebo or randomization involved, reflecting real-world treatment patterns. During the study, researchers monitor adverse events over an average of three years to evaluate safety. They also measure changes in eczema severity and patient-reported symptoms over six months using standardized tools like the Eczema Area and Severity Index (EASI) and the Patient Oriented Eczema Measure (POEM). Participants are expected to follow study requirements and provide data to help understand treatment impact, with ongoing safety and effectiveness evaluations throughout the observation period.

CONDITIONS

Brief Title

Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Paediatric and adult patients with atopic eczema starting or switching to a specific systemic immuno-modulatory agent for the first time
  • Diagnosis of atopic eczema according to UK or Irish criteria
  • Willingness to comply with all study requirements
Not Eligible

You will not qualify if you...

  • Insufficient understanding of the study by the patient or parent/guardian
  • Current participation in a randomized clinical trial
  • Planning to move to a different geographic area within the next 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 3 years

Participants receive systemic drug treatment for atopic dermatitis as prescribed in routine clinical practice.

Visits according to routine clinical care over the treatment period

Follow-up

Duration - Up to 3 years

Participants are monitored for adverse events and changes in disease severity after starting treatment.

Periodic assessments during follow-up visits

Trial Site Locations

Total: 9 locations

1

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Actively Recruiting

2

Hospital General Universitario de Alicante

Alicante, Spain

Actively Recruiting

3

Hospital del Mar IMIM

Barcelona, Spain

Actively Recruiting

4

Hospital Universitario de Gran Canaria Dr Negrín

Las Palmas, Spain

Actively Recruiting

5

Hospital Infanta Leonor

Madrid, Spain

Actively Recruiting

6

Hospital Universitario de la Princesa

Madrid, Spain

Actively Recruiting

7

Complexo Hospitalario Universitario de Pontevedra

Pontevedra, Spain

Actively Recruiting

8

Hospital Universitario y Politécnico la Fe

Valencia, Spain

Actively Recruiting

9

Hospital Miguel Servet

Zaragoza, Spain

Actively Recruiting

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Research Team

I

Ignacio Garcia-Doval

M

Miguel Angel Descalzo Gallego

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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