NCT05674695 Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
| NCT ID | NCT05674695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundación Academia Española de Dermatología |
| Condition | Dermatitis, Atopic |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2029-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2019-01-01 with a primary completion date of 2029-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice. The main objectives are: 1. To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance). 2. To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines. Secondary objectives are: 1. To assess short and long-term safety of topical therapies for atopic eczema. 2. To assess effectiveness of different methods of care, including patient training. 3. To describe atopic dermatitis comorbidities.
Eligibility Criteria
Inclusion Criteria: 1. Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) for the first time in their life (might have received others, but not this specific one). 2. Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria. 3. Willingness to comply with all study requirements. Exclusion Criteria: 1. Insufficient understanding of the study by the patient and/or parent/guardian. 2. Patients who are currently participating in a randomised clinical trial. 3. Intention to move to a different geographical area in a short-term (next 3 months).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05674695 clinical trial?
This trial is open to participants of all sexes, studying Dermatitis, Atopic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05674695 currently recruiting?
Yes, NCT05674695 is actively recruiting participants. Contact the research team at investigacion@aedv.es for enrollment information.
Where is the NCT05674695 trial being conducted?
This trial is being conducted at Badalona, Spain, Alicante, Spain, Barcelona, Spain, Las Palmas, Spain and 5 additional locations.
Who is sponsoring the NCT05674695 clinical trial?
NCT05674695 is sponsored by Fundación Academia Española de Dermatología. The trial plans to enroll 2,500 participants.