Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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